A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With GEMOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- biological test
- Conditions
- Cholangiocarcinoma of the Extrahepatic Bile Duct
- Sponsor
- Shanghai Jiao Tong University School of Medicine
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- Progression Free Survival
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.
Detailed Description
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study.These information will be used to recommend target therapy which may be more likely to result in a beneficial response.Patients will receive target anti-tumor agents according to the result of genomic and proteomic profiling.
Investigators
liu yingbin
head of general surgery department，xin hua Hospital
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility Criteria
Inclusion Criteria
- •Stable vital signs, KPS≥60;
- •Patients have a diagnosis of advanced or recurrent metastatic extrahepatic cholangiocarcinoma or gallbladder carcinoma by histopathology or cytopathology, who are not suitable for radical surgery or have progressed R1 resection or palliative surgery;
- •Adequate fresh tumor tissue for genome sequencing and immuno-histochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components;
- •At least one measurable and evaluable site of disease according to the RECIST criteria version 1.1;
- •Life expectancy of more than 12 weeks;
- •Adequate hepatic, hematologic and renal functions(ALT≤10×upper limit of normal (ULN), AST≤10×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\^9/L, neutrophils≥1.5×10\^9/L, platelets≥80×10\^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
- •Volunteer for this study, have written informed consent and have good Patient compliance;
- •Female patients of childbearing potential and their mates agree to avoid pregnancy.
Exclusion Criteria
- •Have received following treatment before this study:
- •Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months;
- •lesions have been treated by irradiation;
- •participate in other therapeutic or interventional clinical trials.
- •Have central nervous system metastasis;
- •History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
- •Have symptomatic ascites and need for treatment;
- •Have serious concurrent illness including, but not limited to
- •uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure \>21.3 Kpa or diastolic blood pressure \>13.3 Kpa);
- •ongoing or active serious infection;
Arms & Interventions
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: biological test
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: GEMOX
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Cetuximab
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Trastuzumab
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Gefitinib
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Lapatinib
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Everolimus
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Sorafenib
target therapy
The patients wil receive conventional chemotherapy(GEMOX) combined with target agents according to the result of genomic and proteomic profiling of tumor tissue.
Intervention: Crizotinib
GEMOX
The patients wil receive conventional chemotherapy(GEMOX).
Intervention: biological test
GEMOX
The patients wil receive conventional chemotherapy(GEMOX).
Intervention: GEMOX
Outcomes
Primary Outcomes
Progression Free Survival
Time Frame: up to 1 year
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year. The progression is defined consistent with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria for solid tumors.
Secondary Outcomes
- Overall survival(up to 2 years)
- percentage of patients with Clinical Benefit Response(up to 1 year)
- Objective Response Rate(up to 1 year)
- Disease Control Rate(up to 1 year)