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Clinical Trials List

Protocol NumberFF01

2014-07-01 - 2020-12-31

Phase III

Terminated7

ICD-10C11.9

Malignant neoplasm of nasopharynx, unspecified

ICD-10C11

Malignant neoplasm of nasopharynx

A Multicentre, Randomized, Open-Label, Phase III Clinical Trial Of Gemcitabine And Carboplatin Followed By Epstein-Barr Virus-Specific Autologous Cytotoxic T Lymphocytes Versus Gemcitabine And Carboplatin As First Line Treatment For Advanced Nasopharyngeal Carcinoma Patients

  • Trial Applicant

    CMIC Asia-Pacific

  • Sponsor

    Tessa Therapeutics

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator RUEY-LONG HONG Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 林進清 Division of Radiation Therapy
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 黃泰霖 Division of Hematology & Oncology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Muh-Hwa Yang Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Audit

None

Principal Investigator 王全正 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ching Yun Hsieh 未分科
China Medical University Hospital-Taipei

Co-Principal Investigator

Audit

CRO

Principal Investigator Hung-Ming Wang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

11 Terminated

Audit

None

Principal Investigator Ching Yun Hsieh Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

8 Terminated

Condition/Disease

Advanced Nasopharyngeal Carcinoma

Objectives

In our recently completed single arm Phase 2 trial of first-line gemcitabine and carboplatin (GC) for four cycles followed by autologous EBV-specific CTLs in 38 patients, we showed that such an approach is feasible and has comparably very good efficacy with a favorable toxicity profile (52). This is, to date, the largest T cell therapy study for NPC and has achieved the best survival outcome for patients with advanced stage disease. It is only logical that a randomized trial be carried out to accurately assess if combined gemcitabine-carboplatin followed by adoptive T cell therapy would improve clinical outcome for patients with advanced NPC.

Test Drug

Epstein-Barr virus-specific autologous cytotoxic T lymphocytes

Active Ingredient

Epstein-Barr virus-specific autologous cytotoxic T lymphocytes

Dosage Form

細胞培養注射液

Dosage

1毫升細胞液內含2 x 10^7個細胞

Endpoints

Primary:
Assess the efficacy of CTL following first line
chemotherapy in prolonging Overall Survival (OS) of
patients with advanced NPC
Secondary:
• Assess the efficacy of CTL in delaying disease
progression (PFS) in patients with advanced NPC
• Compare the Overall Response Rate, Clinical
Benefit Rate and Quality of Life of patients
undergoing the 2 treatment arms
Exploratory:
• Demonstrate persistence of EBV specific immune
response in Arm A
• Evaluate biomarkers of response to therapy and in
relation to outcome indices

Inclution Criteria

1) Metastatic or locally recurrent EBV-positive,
undifferentiated, non-keratinizing Nasopharyngeal
carcinoma* who do not have curative options such
as chemo-radiation or surgery
*Subjects will be enrolled based on confirmed histology
diagnosis of the NPC
2) Radiologically measurable disease
3) HIV negative*
* Status of HIV must be confirmed via a HIV antibody
test or other confirmatory tests available within 12
months before screening or at screening
4) Bilirubin <2 x upper limit of normal and AST, ALT
<3 x upper limit of normal
5) Calculated CRCL ≥ 40ml/min
6) Normal corrected calcium levels
7) Absolute neutrophil count >1200 /mm3
, Hb ≥ 10
gm/dL and Plts ≥ 100 000 /mm3
8) Male or female
9) Age > or = 21 years
10) ECOG PS ≤2
11) Written informed consent
12) Life expectancy > 3 months

Exclusion Criteria

1) Severe concomitant illness i.e. COPD, IHD, active CCF,
active angina pectoris, uncontrolled arrhythmia,
uncontrolled hypertension
2) HIV Positive*
* Status of HIV must be confirmed via a HIV antibody
test or other confirmatory tests available within 12
months before screening or at screening
3) Pregnant or lactating females
4) Refuse use of contraception during trial (both male
and female patients)
5) Investigational therapy less than one month prior to
study entry
6) Pre-existing peripheral neuropathy (NCI CTCAE
≥2)
7) Central nervous system metastasis
8) Previous or concurrent cancer that is distinct in
primary site or histology from the cancer being
evaluated in this study, EXCEPT cervical
carcinoma in situ, treated basal cell carcinoma,
superficial bladder tumors [Ta, Tis & T1] or any
cancer curatively treated >3 years prior to study
entry
9) Positive HBsAg results
10) Known history of hepatitis C and recovery status
has not been determined at time of screening
11) Prior chemotherapy with gemcitabine or
carboplatin within 6 months prior to time of
screening
12) Prior exposure to palliative gemcitabine
13) Prior chemotherapy for metastatic or locally
recurrent disease, unless it was part of a
chemoradiation regimen with curative intent
previously
14) Severe intercurrent infections

The Estimated Number of Participants

  • Taiwan

    120 participants

  • Global

    330 participants

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