Clinical Trials List
Protocol NumberJS001-015-III-NPC
NCT Number(ClinicalTrials.gov Identfier)NCT03581786
2018-07-01 - 2021-12-31
Phase III
Terminated7
ICD-10C11.9
Malignant neoplasm of nasopharynx, unspecified
ICD-10C11
Malignant neoplasm of nasopharynx
A Phase III, Randomized, Placebo Controlled, Multicenter, Double-Blind Study Comparing Toripalimab Injection (JS001) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasopharyngeal Cancer
-
Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
-
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 陳建志 Division of Radiation Therapy
- YI-CHUN LIU Division of Radiation Therapy
- 李權 Division of Radiation Therapy
- 林柏儒 Division of Radiation Therapy
- 林敬薇 Division of Radiation Therapy
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Sheng-Yu Chen Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
- 陳盛裕 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
None
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Linkou Chang Gung Medical Foundation
Taiwan National PI
王宏銘
Co-Principal Investigator
- Cheng-Lung Hsu Division of Hematology & Oncology
- Chia-Hsun Hsieh Division of Hematology & Oncology
- Tzu-Chen Yen Division of Hematology & Oncology
- Shu-Hang Ag Division of Hematology & Oncology
- Li-Yu Lee Division of Hematology & Oncology
- Chi-Ting Liau Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
4 Terminated
Audit
None
Co-Principal Investigator
- 廖斌志 Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
- YA-FANG CHEN Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Nasopharyngeal Cancer
Objectives
Primary:
• To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus
chemotherapy，as measured by investigator-assessed progression free survival (PFS)
according to RECIST v1.1 in all patients.
Secondary:
• To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus
chemotherapy, as measured by overall survival (OS).
• To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus
chemotherapy, as measured by investigator-assessed overall response rate (ORR), duration
of response (DoR), disease control rate (DCR) according to RECIST v1.1.
• To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus
chemotherapy, as measured by an independent monitoring committee (iDMC)-assessed PFS
according to RECIST v1.1.
• To evaluate the PFS rate at 1 and 2 years in each treatment arm.
• To evaluate the OS rate at 1 and 2 years in each treatment arm.
• To assess disease-related symptoms and health related quality of life (HRQoL) in patients
treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the
EORTC QLQ-C30, EORTC QLQ-H&N35 and ECOG performance status assessments.
• To evaluate the safety and tolerability of JS001 plus chemotherapy compared with placebo
plus chemotherapy.
• To evaluate the incidence and titers of ADAs against JS001 and to explore the potential
relationship of the immunogenicity response with pharmacodynamics, safety and efficacy.
• To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus
chemotherapy，as measured by PFS, ORR, DoR and DCR according to irRECIST.
Exploratory:
To assess predictive, prognostic, and pharmacodynamic exploratory biomarkers (including but
not limited to PMBC, PD-L1, PD-1, tumor mutation burden and others) in archival and/or fresh
tumor tissue and blood and their association with disease status, mechanisms of resistance,
and/or response to JS001.
To evaluate the utility of biopsy at the time of apparent disease progression to distinguish
apparent increases in tumor volume related to the immunomodulatory activity of JS001 (i.e.,
pseudoprogression and tumor immune infiltration) from true disease progression .
Test Drug
JS001
Active Ingredient
JS001
Dosage Form
single-use vial for intravenous infusion
Dosage
40 mg/ mL
Endpoints
Primary Endpoint:
Progression-free survival defined as the time from randomization to the time of first documented
disease progression or death due to any cause (whichever occur first). Kaplan-Meier methods will
be used.
Secondary Endpoints:
Clinical response according to RECIST version 1.1 to evaluate ORR, DoR, and DCR.
o ORR, defined as the proportion of patients with best overall response of complete or
partial response
o DoR, defined as the time between first documentation of a response and first
evidence of progressive disease
o DCR, defined as the proportion of patients with best response of CR or PR or SD.
Clinical response according to irRECIST. In cases the Investigator suspects progressive
disease corresponds to a pseudo-progression, such as an increase in tumor burden (including
the appearance of small new lesions in new non vital areas), in the absence of significant
deterioration of performance status and laboratory values, treatment continuation is allowed
until confirmation of progression with repeat imaging at least 4 weeks later or at the next
regularly scheduled imaging time point.
Progression-free survival defined as the time from randomization to the time of first documented
disease progression or death due to any cause (whichever occur first). Kaplan-Meier methods will
be used.
Secondary Endpoints:
Clinical response according to RECIST version 1.1 to evaluate ORR, DoR, and DCR.
o ORR, defined as the proportion of patients with best overall response of complete or
partial response
o DoR, defined as the time between first documentation of a response and first
evidence of progressive disease
o DCR, defined as the proportion of patients with best response of CR or PR or SD.
Clinical response according to irRECIST. In cases the Investigator suspects progressive
disease corresponds to a pseudo-progression, such as an increase in tumor burden (including
the appearance of small new lesions in new non vital areas), in the absence of significant
deterioration of performance status and laboratory values, treatment continuation is allowed
until confirmation of progression with repeat imaging at least 4 weeks later or at the next
regularly scheduled imaging time point.
Inclution Criteria
To be eligible to participate in the study, patients must meet all
of the following Inclusion Criteria:
1. Age ≥ 18 years and ≤75 years.
2. An archival tumor specimen or fresh tumor biopsy sample is
available.
3. Histological/cytological confirmation of NPC.
4. Primarily metastatic (stage IVB as defined by the
International Union against Cancer and American Joint
Committee on Cancer staging system for NPC, eighth
edition) or recurrent NPC that is not amenable for local
regional treatment or curative treatment.
5. Patients did not receive systemic chemotherapy for
recurrent or metastatic disease, except for prior induction,
concurrent, or adjuvant chemotherapy that was
completed > 6 months prior to randomization. Prior
radiotherapy or C-RT should be completed > 6 months prior
to randomization.
6. At least 1 measurable lesion according to RECIST version
1.1.
7. Life expectancy ≥ 3 months.
8. Performance status 0 or 1 according to the Eastern
Cooperative Oncology Group (ECOG) criteria (Appendix 3).
9. Adequate organ function:
Hematologic: leucocytes ≥ 4,000/ μL, granulocytes ≥
2.000/μL, hemoglobin ≥ 9 g/dL, and platelets ≥
100,000/μL.
Hepatic: bilirubin ≤ 1.5 × upper limit of normal
(ULN)(patients with known Gilbert’s disease who have
serum bilirubin level ≤ 3 × ULN may be enrolled),
AST and ALT ≤ 3 × ULN (AST/ALT ≤ 5 × ULN if liver
metastases), with alkaline phosphatase≤ 3 ×
ULN(ALP≤5×ULN if liver or bone metastases); albumin
≥ 3 g/dL;
International Normalized Ratio (INR) or Prothrombin
Time (PT) or Activated Partial Thromboplastin Time
(aPTT) ≤ 1.5 × ULN.
Renal: serum creatinine ≤ 1.5 ULN or creatinine
clearance≥ 60 mL/min according to Cockcroft-Gault
formula (Appendix 8)
10. Toxicities from any prior therapy, surgery, or radiotherapy
must have resolved to Grade 0 or 1 as per the National
Cancer Institute-Common Terminology Criteria for Adverse
Events (NCI-CTCAE 5.0), excluding any grade alopecia.
11. Willingness and ability to comply with scheduled visits,
treatment plans, laboratory tests and other study
procedures.
12. Female patients are eligible to enter and participate in the
study if they are of:
Non-childbearing potential (i.e., physiologically
incapable of becoming pregnant), including any female
who
o Has had a hysterectomy,
o Has had a bilateral oophorectomy (ovariectomy),
o Has had a bilateral tubal ligation, or
o Is post-menopausal (total cessation of menses for
≥1 year).
Childbearing potential, has a negative serum
pregnancy test at screening (within 7 days of the first
investigational product administration), and uses
adequate contraception before study entry and
throughout the study until 60 days after the last
investigational product administration. Adequate
contraception, when used consistently and in
accordance with both the product label and the
instructions of the physician, are defined as follows:
o Any intrauterine device with a documented failure
rate of less than 1% per year.
o Double barrier contraception defined as condom
with spermicidal jelly, foam, suppository, or film;
OR diaphragm with spermicide; OR male condom
and diaphragm.
of the following Inclusion Criteria:
1. Age ≥ 18 years and ≤75 years.
2. An archival tumor specimen or fresh tumor biopsy sample is
available.
3. Histological/cytological confirmation of NPC.
4. Primarily metastatic (stage IVB as defined by the
International Union against Cancer and American Joint
Committee on Cancer staging system for NPC, eighth
edition) or recurrent NPC that is not amenable for local
regional treatment or curative treatment.
5. Patients did not receive systemic chemotherapy for
recurrent or metastatic disease, except for prior induction,
concurrent, or adjuvant chemotherapy that was
completed > 6 months prior to randomization. Prior
radiotherapy or C-RT should be completed > 6 months prior
to randomization.
6. At least 1 measurable lesion according to RECIST version
1.1.
7. Life expectancy ≥ 3 months.
8. Performance status 0 or 1 according to the Eastern
Cooperative Oncology Group (ECOG) criteria (Appendix 3).
9. Adequate organ function:
Hematologic: leucocytes ≥ 4,000/ μL, granulocytes ≥
2.000/μL, hemoglobin ≥ 9 g/dL, and platelets ≥
100,000/μL.
Hepatic: bilirubin ≤ 1.5 × upper limit of normal
(ULN)(patients with known Gilbert’s disease who have
serum bilirubin level ≤ 3 × ULN may be enrolled),
AST and ALT ≤ 3 × ULN (AST/ALT ≤ 5 × ULN if liver
metastases), with alkaline phosphatase≤ 3 ×
ULN(ALP≤5×ULN if liver or bone metastases); albumin
≥ 3 g/dL;
International Normalized Ratio (INR) or Prothrombin
Time (PT) or Activated Partial Thromboplastin Time
(aPTT) ≤ 1.5 × ULN.
Renal: serum creatinine ≤ 1.5 ULN or creatinine
clearance≥ 60 mL/min according to Cockcroft-Gault
formula (Appendix 8)
10. Toxicities from any prior therapy, surgery, or radiotherapy
must have resolved to Grade 0 or 1 as per the National
Cancer Institute-Common Terminology Criteria for Adverse
Events (NCI-CTCAE 5.0), excluding any grade alopecia.
11. Willingness and ability to comply with scheduled visits,
treatment plans, laboratory tests and other study
procedures.
12. Female patients are eligible to enter and participate in the
study if they are of:
Non-childbearing potential (i.e., physiologically
incapable of becoming pregnant), including any female
who
o Has had a hysterectomy,
o Has had a bilateral oophorectomy (ovariectomy),
o Has had a bilateral tubal ligation, or
o Is post-menopausal (total cessation of menses for
≥1 year).
Childbearing potential, has a negative serum
pregnancy test at screening (within 7 days of the first
investigational product administration), and uses
adequate contraception before study entry and
throughout the study until 60 days after the last
investigational product administration. Adequate
contraception, when used consistently and in
accordance with both the product label and the
instructions of the physician, are defined as follows:
o Any intrauterine device with a documented failure
rate of less than 1% per year.
o Double barrier contraception defined as condom
with spermicidal jelly, foam, suppository, or film;
OR diaphragm with spermicide; OR male condom
and diaphragm.
Exclusion Criteria
Patients will be excluded from the study, if any of the following
criteria is met:
1. History of severe hypersensitivity reactions to other mAbs
or any ingredient of JS001.
2. Active or untreated CNS metastases (e.g., brain or
leptomeningeal), as determined on CT or magnetic
resonance imaging (MRI) evaluation during screening and
prior radiographic assessments. Patients who have prior therapies for brain or leptomeningeal metastasis and has
been stabilized for ≥ 2 months and has discontinued
systemic hormone therapy (>10 mg/day prednisone or
equivalent) > 4 weeks prior to randomization could be
included.
3. Spinal cord compression not definitively treated with
surgery and/or radiation or previously diagnosed and
treated spinal cord compression without evidence that
disease has been clinically stable for 2 weeks prior to
randomization
4. Patients with necrotic lesions have potential risk of massive
hemorrhage at the discretion of investigator.
5. Uncontrolled pleural effusion, pericardial effusion, or ascites
requiring recurrent drainage procedures
Patients with indwelling catheters (e.g., PleurX® catheter)
are allowed.
6. Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable
regimen at study entry.
Symptomatic lesions amenable to palliative radiotherapy
(e.g., bone metastases or metastases causing nerve
impingement) should be treated prior to enrollment.
Asymptomatic metastatic lesions whose further growth
would likely cause functional deficits or intractable pain
(e.g., epidural metastasis that is not presently associated
with spinal cord compression) should be considered for
loco-regional therapy, if appropriate, prior to enrollment.
7. Uncontrolled or symptomatic hypercalcemia ( 1.5 mmol/L
ionized calcium or Ca 12 mg/dL or corrected serum
calcium greater than the ULN)
8. Malignancies other than NPC within 5 years prior to
randomization, with the exception of those with a negligible
risk of metastasis or death (e.g., expected 5-year OS
90%) treated with expected curative outcome (such as
adequately treated carcinoma in situ of the cervix, basal or
squamous cell skin cancer, localized prostate cancer
treated with curative intent, ductal carcinoma in situ treated
surgically with curative intent)
9. Prior therapy targeting PD-1 receptor, or its ligand PD-L1,
or cytotoxic T-lymphocyte-associated protein 4 (CTLA4)
receptor.
10. Use of antineoplastic traditional herbal medicine within 4
weeks before randomization.
11. Major surgical procedure other than for diagnosis of NPC
within 28 days prior to randomization or anticipation of need
for a major surgical procedure during the study.
12. History of autoimmune disease, including, but not limited to,
myasthenia gravis, myositis, autoimmune hepatitis,
systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener
granulomatosis, Sjögren syndrome, Guillain-Barré
syndrome, multiple sclerosis, vasculitis, or
glomerulonephritis (see Appendix 11 for a more
comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related
hypothyroidism on a stable dose of thyroid-replacement
hormone may be eligible for this study.
Patients with controlled Type I diabetes mellitus on a
stable insulin regimen are eligible for this study.
13. Treatment with systemic immunostimulatory agents
(including, but not limited to, interferons or IL-2) within 4
weeks or five half-lives of the drug, whichever is shorter,
prior to randomization
14. Treatment with systemic corticosteroids (> 10 mg daily
prednisone equivalents) or other systemic
immunosuppressive medications (including, but not limited
to, prednisone, dexamethasone, cyclophosphamide,
azathioprine, methotrexate, thalidomide, and antitumor
necrosis factor [anti-TNF] agents) within 2 weeks prior to
randomization. Use of topical, ocular, intra-articular,
intranasal, and inhalational corticosteroids is allowed.
Patients who have received acute, low-dose, systemic
immunosuppressant medications (e.g., a one-time dose
of dexamethasone for nausea) may be enrolled in the
study after discussion with and approval by the Medical
Monitor.
Patients with history of allergic reaction to IV contrast
requiring steroid pre-treatment should have baseline and
subsequent tumor assessments performed on MRI.
The use of inhaled corticosteroids for chronic obstructive
pulmonary disease, mineralocorticoids (e.g.,
fludrocortisone) for patients with orthostatic hypotension,
and low-dose supplemental corticosteroids for
adrenocortical insufficiency is allowed.
15. Patients with prior allogeneic bone marrow transplantation
or prior solid organ transplantation
16. History of idiopathic pulmonary fibrosis, drug-induced
pneumonitis, organizing pneumonia (i.e., bronchiolitis
obliterans), idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan.
17. History of hypersensitivity to gemcitabine or cisplatin or to
any of the excipients.
18. Use of any live vaccines (e.g., against infectious diseases
such as influenza, varicella, etc.) within 4 weeks (28 days)
before randomization.
19. Active infection including tuberculosis (clinical evaluation
that includes clinical history, physical examination and
radiographic findings, and TB testing in line with local
practice), hepatitis B (known positive HBV surface antigen
(HBsAg) result), hepatitis C, or human immunodeficiency
virus (positive HIV antibodies).
Patients with a past or resolved HBV infection (defined as
the presence of hepatitis B core antibody [anti-HBc] and
absence of HBsAg) are eligible only if they are negative for
HBV DNA (HBV DNA ˂1000cps/ml).
Patients positive for hepatitis C (HCV) antibody are eligible
only if polymerase chain reaction is negative for HCV RNA.
20. Underlying medical conditions with clinical significance
(such as dyspnea, pneumonitis, pancreatitis, uncontrollable diabetes, active or uncontrollable infection, drug or alcohol
abuse, or psychiatric conditions), which in the Investigator’s
opinion can affect the administration of study drugs and
protocol compliance.
21. Presence of a significant neurological or psychiatric
disease, including dementia and seizures.
22. Have NCI-CTCAE ≥ Grade 2 peripheral neuropathy.
23. Female patients who are at pregnancy or lactation.
24. Significant cardiovascular disease, such as New York Heart
Association cardiac disease (Class II or greater, Appendix
6), myocardial infarction within 3 months prior to
randomization, unstable arrhythmias, or unstable angina
Patients with known coronary artery disease, congestive
heart failure not meeting the above criteria, or left
ventricular ejection fraction 50% must be on a stable
medical regimen that is optimized in the opinion of the
treating physician, in consultation with a cardiologist if
appropriate.
criteria is met:
1. History of severe hypersensitivity reactions to other mAbs
or any ingredient of JS001.
2. Active or untreated CNS metastases (e.g., brain or
leptomeningeal), as determined on CT or magnetic
resonance imaging (MRI) evaluation during screening and
prior radiographic assessments. Patients who have prior therapies for brain or leptomeningeal metastasis and has
been stabilized for ≥ 2 months and has discontinued
systemic hormone therapy (>10 mg/day prednisone or
equivalent) > 4 weeks prior to randomization could be
included.
3. Spinal cord compression not definitively treated with
surgery and/or radiation or previously diagnosed and
treated spinal cord compression without evidence that
disease has been clinically stable for 2 weeks prior to
randomization
4. Patients with necrotic lesions have potential risk of massive
hemorrhage at the discretion of investigator.
5. Uncontrolled pleural effusion, pericardial effusion, or ascites
requiring recurrent drainage procedures
Patients with indwelling catheters (e.g., PleurX® catheter)
are allowed.
6. Uncontrolled tumor-related pain
Patients requiring pain medication must be on a stable
regimen at study entry.
Symptomatic lesions amenable to palliative radiotherapy
(e.g., bone metastases or metastases causing nerve
impingement) should be treated prior to enrollment.
Asymptomatic metastatic lesions whose further growth
would likely cause functional deficits or intractable pain
(e.g., epidural metastasis that is not presently associated
with spinal cord compression) should be considered for
loco-regional therapy, if appropriate, prior to enrollment.
7. Uncontrolled or symptomatic hypercalcemia ( 1.5 mmol/L
ionized calcium or Ca 12 mg/dL or corrected serum
calcium greater than the ULN)
8. Malignancies other than NPC within 5 years prior to
randomization, with the exception of those with a negligible
risk of metastasis or death (e.g., expected 5-year OS
90%) treated with expected curative outcome (such as
adequately treated carcinoma in situ of the cervix, basal or
squamous cell skin cancer, localized prostate cancer
treated with curative intent, ductal carcinoma in situ treated
surgically with curative intent)
9. Prior therapy targeting PD-1 receptor, or its ligand PD-L1,
or cytotoxic T-lymphocyte-associated protein 4 (CTLA4)
receptor.
10. Use of antineoplastic traditional herbal medicine within 4
weeks before randomization.
11. Major surgical procedure other than for diagnosis of NPC
within 28 days prior to randomization or anticipation of need
for a major surgical procedure during the study.
12. History of autoimmune disease, including, but not limited to,
myasthenia gravis, myositis, autoimmune hepatitis,
systemic lupus erythematosus, rheumatoid arthritis,
inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener
granulomatosis, Sjögren syndrome, Guillain-Barré
syndrome, multiple sclerosis, vasculitis, or
glomerulonephritis (see Appendix 11 for a more
comprehensive list of autoimmune diseases) Patients with a history of autoimmune-related
hypothyroidism on a stable dose of thyroid-replacement
hormone may be eligible for this study.
Patients with controlled Type I diabetes mellitus on a
stable insulin regimen are eligible for this study.
13. Treatment with systemic immunostimulatory agents
(including, but not limited to, interferons or IL-2) within 4
weeks or five half-lives of the drug, whichever is shorter,
prior to randomization
14. Treatment with systemic corticosteroids (> 10 mg daily
prednisone equivalents) or other systemic
immunosuppressive medications (including, but not limited
to, prednisone, dexamethasone, cyclophosphamide,
azathioprine, methotrexate, thalidomide, and antitumor
necrosis factor [anti-TNF] agents) within 2 weeks prior to
randomization. Use of topical, ocular, intra-articular,
intranasal, and inhalational corticosteroids is allowed.
Patients who have received acute, low-dose, systemic
immunosuppressant medications (e.g., a one-time dose
of dexamethasone for nausea) may be enrolled in the
study after discussion with and approval by the Medical
Monitor.
Patients with history of allergic reaction to IV contrast
requiring steroid pre-treatment should have baseline and
subsequent tumor assessments performed on MRI.
The use of inhaled corticosteroids for chronic obstructive
pulmonary disease, mineralocorticoids (e.g.,
fludrocortisone) for patients with orthostatic hypotension,
and low-dose supplemental corticosteroids for
adrenocortical insufficiency is allowed.
15. Patients with prior allogeneic bone marrow transplantation
or prior solid organ transplantation
16. History of idiopathic pulmonary fibrosis, drug-induced
pneumonitis, organizing pneumonia (i.e., bronchiolitis
obliterans), idiopathic pneumonitis, or evidence of active
pneumonitis on screening chest CT scan.
17. History of hypersensitivity to gemcitabine or cisplatin or to
any of the excipients.
18. Use of any live vaccines (e.g., against infectious diseases
such as influenza, varicella, etc.) within 4 weeks (28 days)
before randomization.
19. Active infection including tuberculosis (clinical evaluation
that includes clinical history, physical examination and
radiographic findings, and TB testing in line with local
practice), hepatitis B (known positive HBV surface antigen
(HBsAg) result), hepatitis C, or human immunodeficiency
virus (positive HIV antibodies).
Patients with a past or resolved HBV infection (defined as
the presence of hepatitis B core antibody [anti-HBc] and
absence of HBsAg) are eligible only if they are negative for
HBV DNA (HBV DNA ˂1000cps/ml).
Patients positive for hepatitis C (HCV) antibody are eligible
only if polymerase chain reaction is negative for HCV RNA.
20. Underlying medical conditions with clinical significance
(such as dyspnea, pneumonitis, pancreatitis, uncontrollable diabetes, active or uncontrollable infection, drug or alcohol
abuse, or psychiatric conditions), which in the Investigator’s
opinion can affect the administration of study drugs and
protocol compliance.
21. Presence of a significant neurological or psychiatric
disease, including dementia and seizures.
22. Have NCI-CTCAE ≥ Grade 2 peripheral neuropathy.
23. Female patients who are at pregnancy or lactation.
24. Significant cardiovascular disease, such as New York Heart
Association cardiac disease (Class II or greater, Appendix
6), myocardial infarction within 3 months prior to
randomization, unstable arrhythmias, or unstable angina
Patients with known coronary artery disease, congestive
heart failure not meeting the above criteria, or left
ventricular ejection fraction 50% must be on a stable
medical regimen that is optimized in the opinion of the
treating physician, in consultation with a cardiologist if
appropriate.
The Estimated Number of Participants
-
Taiwan
19 participants
-
Global
350 participants
