Clinical Trials List
Protocol NumberLP0190415
NCT Number(ClinicalTrials.gov Identfier)NCT04222114
2020-05-01 - 2023-01-31
Others
Recruiting4
A two-stage, multi-center, open-label, randomized, controlled trial comparing the efficacy and safety of intra-peritoneal infusion of catumaxomab and treatment of investigator choice in patients with advanced gastric carcinoma with peritoneal metastasis
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Guangzhou LintonPharm Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shang-Wen Chen Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chang-Fang Chiu Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 趙盈瑞 Division of General Surgery
- 王志榮 Division of General Surgery
- Chien-Jui Huang Division of General Internal Medicine
- 劉奕廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
advanced gastric carcinoma with peritoneal metastasis
Objectives
"The main purpose of the comparison partner:
To compare the efficacy and safety of patients with advanced gastric cancer with peritoneal metastasis who received catumaxomab intraperitoneal infusion and the treatment selected by the trial host.
Secondary purpose:
To evaluate the safety of catumaxomab perfusion in the abdominal cavity.
To evaluate the pharmacokinetic/pharmacodynamic characteristics of catumaxomab perfused into the abdominal cavity. Patients with advanced gastric cancer who metastasized to the peritoneum received intraperitoneal infusion of catumaxomab and the trial host’s choice of treatment efficacy and safety. "
Test Drug
Catumaxomab
Active Ingredient
Catumaxomab
Dosage Form
solution for intra-peritoneal infusion
Dosage
100 μg/mL
Endpoints
main indicators:
Overall survival (OS): Defined as the time from random to death due to any cause.
Secondary indicators:
Progression-free survival (PFS): defined as the time from random start to progression (PD) or death due to any cause according to the RECIST v1.1 standard, whichever occurs first.
Progression-free stage of peritoneal metastasis: In subjects with ascites content greater than or equal to 300ml, it is defined as the time from the first intraperitoneal infusion to the progression of ascites according to the five-point method 2 evaluation; and those without ascites or ascites content less than 300ml Subjects, according to RECIST V1.1 evaluation criteria, the time from the first intraperitoneal infusion to the progression of the peritoneal lesion.
Objective Response Rate (ORR): Defined as the proportion of subjects whose overall efficacy is evaluated as CR and PR according to the RECIST v1.1 standard;
Clinical benefit rate (CBR): Defined as the proportion of subjects whose best overall efficacy evaluation is SD, PR, and CR according to the RECIST v1.1 standard.
Duration of Remission (DoR): Defined as the time from remission to diagnosis of PD according to the RECIST V1.1 standard.
Duration of ascites remission: defined as the time from the first ascites remission to ascites progression based on the five-point method.
According to the National Cancer Institute Commonly Used Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, the incidence and severity of related adverse events (TEAE) were compared between catumaxomab and the treatment group selected by the trial host.
DLT event rate: Only evaluated in the first stage, defined as the DLT event rate from the first infusion to 6 weeks after the first infusion.
The pharmacokinetic parameters of catumaxomab in plasma by intraperitoneal infusion.
The incidence of anti-drug antibodies (ADA) in the serum of catumaxomab.
Peripheral blood lymphocyte count changes with catumaxomab perfusion.
Overall survival (OS): Defined as the time from random to death due to any cause.
Secondary indicators:
Progression-free survival (PFS): defined as the time from random start to progression (PD) or death due to any cause according to the RECIST v1.1 standard, whichever occurs first.
Progression-free stage of peritoneal metastasis: In subjects with ascites content greater than or equal to 300ml, it is defined as the time from the first intraperitoneal infusion to the progression of ascites according to the five-point method 2 evaluation; and those without ascites or ascites content less than 300ml Subjects, according to RECIST V1.1 evaluation criteria, the time from the first intraperitoneal infusion to the progression of the peritoneal lesion.
Objective Response Rate (ORR): Defined as the proportion of subjects whose overall efficacy is evaluated as CR and PR according to the RECIST v1.1 standard;
Clinical benefit rate (CBR): Defined as the proportion of subjects whose best overall efficacy evaluation is SD, PR, and CR according to the RECIST v1.1 standard.
Duration of Remission (DoR): Defined as the time from remission to diagnosis of PD according to the RECIST V1.1 standard.
Duration of ascites remission: defined as the time from the first ascites remission to ascites progression based on the five-point method.
According to the National Cancer Institute Commonly Used Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, the incidence and severity of related adverse events (TEAE) were compared between catumaxomab and the treatment group selected by the trial host.
DLT event rate: Only evaluated in the first stage, defined as the DLT event rate from the first infusion to 6 weeks after the first infusion.
The pharmacokinetic parameters of catumaxomab in plasma by intraperitoneal infusion.
The incidence of anti-drug antibodies (ADA) in the serum of catumaxomab.
Peripheral blood lymphocyte count changes with catumaxomab perfusion.
Inclution Criteria
Inclusion conditions
Subjects who meet all of the following conditions are eligible to be included in the trial:
1. A signed and dated subject consent form has been provided.
2. Willing to cooperate with the test procedure during the test.
3. When signing the subject's consent form, men or women aged ≥ 18 years old (in Taiwan, only those aged ≥ 20 years old are eligible to take the test).
4. Confirmed by histological or cytological examination to have gastric adenocarcinoma.
5. According to the Standards for Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1, patients with lesions that can be assessed and/or cannot be assessed.
6. Diagnosed with gastric cancer with peritoneal metastasis (imaging examination results, pathological results obtained from previous surgery, positive ascites/peritoneal effusion cytology).
7. In order to treat recurrent or metastatic gastric cancer, after receiving at least two standard systemic anticancer therapies, the treatment still fails.
8. The toxicity caused by the previous treatment has been recovered (according to the National Cancer Institute General Terminology Standard Adverse Event [NCI-CTCAE] Version 5.0 is grade 0-1).
9. Estimated survival time ≥ 3 months.
10. United States East Coast Cancer Clinical Research Cooperative (ECOG) performance status is 0-2 points.
11. Laboratory test values during the screening period are based on the following table:
Hematology
ANC (absolute neutrophil count) ≥ 1.5 × 109/L
Heme ≥ 80 g/L
Platelets ≥ 100 × 109/L
Percentage of lymphocytes ≥ 13%
liver function
Serum bilirubin ≤ 1.25 x upper limit of normal (ULN) (if you have Gilbert’s syndrome, 2.5 x ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if there is no liver metastasis) ≤ 5 × ULN (if there is liver metastasis)
Kidney function
Serum creatinine ≤ 2.0 mg/dL
Or
Calculated creatinine clearance rate ≥30 mL/min
12. For women who may be fertile: use a medically acceptable contraceptive method at least 1 month before screening, and agree to use this contraceptive method from screening until 30 days after the last intraperitoneal infusion.
13. For men with fertility: From screening until 30 days after the last intraperitoneal infusion, use medically acceptable contraceptive measures for sexual partners.
Subjects who meet all of the following conditions are eligible to be included in the trial:
1. A signed and dated subject consent form has been provided.
2. Willing to cooperate with the test procedure during the test.
3. When signing the subject's consent form, men or women aged ≥ 18 years old (in Taiwan, only those aged ≥ 20 years old are eligible to take the test).
4. Confirmed by histological or cytological examination to have gastric adenocarcinoma.
5. According to the Standards for Response Evaluation Criteria for Solid Tumors (RECIST) Version 1.1, patients with lesions that can be assessed and/or cannot be assessed.
6. Diagnosed with gastric cancer with peritoneal metastasis (imaging examination results, pathological results obtained from previous surgery, positive ascites/peritoneal effusion cytology).
7. In order to treat recurrent or metastatic gastric cancer, after receiving at least two standard systemic anticancer therapies, the treatment still fails.
8. The toxicity caused by the previous treatment has been recovered (according to the National Cancer Institute General Terminology Standard Adverse Event [NCI-CTCAE] Version 5.0 is grade 0-1).
9. Estimated survival time ≥ 3 months.
10. United States East Coast Cancer Clinical Research Cooperative (ECOG) performance status is 0-2 points.
11. Laboratory test values during the screening period are based on the following table:
Hematology
ANC (absolute neutrophil count) ≥ 1.5 × 109/L
Heme ≥ 80 g/L
Platelets ≥ 100 × 109/L
Percentage of lymphocytes ≥ 13%
liver function
Serum bilirubin ≤ 1.25 x upper limit of normal (ULN) (if you have Gilbert’s syndrome, 2.5 x ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (if there is no liver metastasis) ≤ 5 × ULN (if there is liver metastasis)
Kidney function
Serum creatinine ≤ 2.0 mg/dL
Or
Calculated creatinine clearance rate ≥30 mL/min
12. For women who may be fertile: use a medically acceptable contraceptive method at least 1 month before screening, and agree to use this contraceptive method from screening until 30 days after the last intraperitoneal infusion.
13. For men with fertility: From screening until 30 days after the last intraperitoneal infusion, use medically acceptable contraceptive measures for sexual partners.
Exclusion Criteria
1. Known or suspected allergy to catumaxomab or similar antibodies.
2. Have received anti-tumor treatment, including other anti-tumor research drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local radiotherapy for pain relief), etc.; the last treatment and the first The interval between intraperitoneal infusions is ≤ 21 days.
3. Extensive liver metastasis (the tumor volume is estimated to account for ≥ 50% of the total liver volume by imaging examination).
4. Known intracranial tumor metastasis.
5. Three days before the first infusion, the following diseases have not yet resolved to CTCAE grade 0-1:
● Poorly controlled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection, etc.;
●Acute or chronic pancreatitis;
●Diarrhea;
●Difficulty breathing
6. New York Heart Association (NYHA) Level 3 or 4.
7. Symptoms and signs of cardiovascular disease: including myocardial infarction, congestive heart failure, and arrhythmia.
8. A cerebrovascular accident is known to occur.
9. Intestinal obstruction occurred 30 days before the first dose.
10. Imaging diagnosis of portal vein obstruction, including tumor compression or portal vein thrombosis, cancer embolism.
11. History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, rheumatoid arthritis, etc.).
12. The patient is known to be human immunodeficiency virus (HIV) seropositive, hepatitis C infection and/or hepatitis B infection (hepatitis B surface antigen [HepBsAg] or core antibody positive, and for anti-hepatitis B virus therapy Patients with therapeutic response are exceptions and can still participate in this trial; Note: Patients who were negative for HepBsAg at the time of screening, or are currently receiving interferon-2a [IFN] or long-acting interferon-2a [Peg-IFN] treatment, Patients with hepatitis B virus [HBV] DNA <2000 International Units [IU], or subjects who received nucleoside [acid] analogs during screening and whose HBV DNA is below the lower limit of normal [LLN] are still eligible to participate This test).
13. Be pregnant or breast-feeding during the trial treatment and follow-up period.
14. Patients with a confirmed history of neurological or psychiatric disorders (including epilepsy or dementia).
15. Suffer from other serious systemic diseases and may restrict patients from participating in this trial (such as poorly controlled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.).
16. Suffering from any other disease, the trial host determines that the patient will bear unnecessary risks and is not suitable for participating in this clinical trial.
2. Have received anti-tumor treatment, including other anti-tumor research drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local radiotherapy for pain relief), etc.; the last treatment and the first The interval between intraperitoneal infusions is ≤ 21 days.
3. Extensive liver metastasis (the tumor volume is estimated to account for ≥ 50% of the total liver volume by imaging examination).
4. Known intracranial tumor metastasis.
5. Three days before the first infusion, the following diseases have not yet resolved to CTCAE grade 0-1:
● Poorly controlled acute and chronic infections, such as pneumonia, biliary tract infection, hepatitis B virus infection and hepatitis C virus infection, etc.;
●Acute or chronic pancreatitis;
●Diarrhea;
●Difficulty breathing
6. New York Heart Association (NYHA) Level 3 or 4.
7. Symptoms and signs of cardiovascular disease: including myocardial infarction, congestive heart failure, and arrhythmia.
8. A cerebrovascular accident is known to occur.
9. Intestinal obstruction occurred 30 days before the first dose.
10. Imaging diagnosis of portal vein obstruction, including tumor compression or portal vein thrombosis, cancer embolism.
11. History of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, rheumatoid arthritis, etc.).
12. The patient is known to be human immunodeficiency virus (HIV) seropositive, hepatitis C infection and/or hepatitis B infection (hepatitis B surface antigen [HepBsAg] or core antibody positive, and for anti-hepatitis B virus therapy Patients with therapeutic response are exceptions and can still participate in this trial; Note: Patients who were negative for HepBsAg at the time of screening, or are currently receiving interferon-2a [IFN] or long-acting interferon-2a [Peg-IFN] treatment, Patients with hepatitis B virus [HBV] DNA <2000 International Units [IU], or subjects who received nucleoside [acid] analogs during screening and whose HBV DNA is below the lower limit of normal [LLN] are still eligible to participate This test).
13. Be pregnant or breast-feeding during the trial treatment and follow-up period.
14. Patients with a confirmed history of neurological or psychiatric disorders (including epilepsy or dementia).
15. Suffer from other serious systemic diseases and may restrict patients from participating in this trial (such as poorly controlled diabetes, cardiovascular and cerebrovascular diseases, severe gastrointestinal diseases, etc.).
16. Suffering from any other disease, the trial host determines that the patient will bear unnecessary risks and is not suitable for participating in this clinical trial.
The Estimated Number of Participants
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Taiwan
2 participants
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Global
297 participants
