Gemcitabine, Oxaliplatin and Capecitabine in locally advanced unresectable/metastatic gall bladder carcinoma: an investigator-initiated phase 2 trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Prognosis of locally advanced unresectable and/or metastatic gall bladder cancer is dismal. The overall survival is around 12 months. Gemcitabine and Platin ( Gemcitabine + CDDP / Gemcitabine + Oxaliplatin ) based doublet has long been the mainstay of treatment. Intensification of chemotherapy with addition of Nab-paclitaxel for improving outcomes has failed recently . Addition of targeted therapies like Durvalumab and Pembrolizumab has showed promising outcomes in biliary tract tumours, however, representation of gall bladder cancers in these study cohorts has been limited. A triple drug combination of Gemcitabine , Oxaliplatin and Capecitabine has been found to be an effective combination in few small phase 2 studies of carcinoma pancreas and biliary tract, with a manageable toxicity profile. This study is undertaken to assess if this triple drug combination is efficacious in improving survival as a first line palliative chemotherapy in carcinoma gall bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •ECOG PS – 0-2
- •Patients must have histologically or cytologically confirmed gallbladder cancer 3.Patients must have documented metastatic or locally advanced unresectable disease on computed tomography (CT) or magnetic resonance (MR) imaging CT scans or MRIs used to assess measurable disease.
- •Must have been completed within 28 days prior to registration.
- •Visceral measurable metastases (at least one lesion > 10mm) and/or measurable and non resectable primary tumor, histopathological (or cytological) proven disease (metastasis or primary site).
- •If there is no visceral metastasis, non-resectability should be confirmed by a hepato-biliary surgeon in a multi-disciplinary meeting.
- •Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer
- •Patient must not have received adjuvant therapy within 6 months prior to registration
- •No prior malignancy or dual malignancy
- •Women/men of reproductive potential must have agreed to use an effective contraceptive method.
- •Must give informed consent before study initiation.
- •Absolute neutrophil count (ANC)  1,500/mcL (obtained within 28 days prior to registration)
- •Platelets  100,000/mcL (obtained within 28 days prior to registration)
- •Hemoglobin 8 g/dL (obtained within 28 days prior to registration)
- •Serum albumin2.8 g/dL (obtained within 28 days prior to registration)
- •Total bilirubin ï‚£ 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to registration)
- •Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ï‚£ 8 x IULN (obtained within 28 days prior to registration)
- •Serum creatinine ï‚£ IULN OR calculated creatinine clearance  60 mL/min (obtained within 28 days prior to registration)
- •Neuropathy- no pre-existing history of peripheral neuropathy > grade 1
- •No history of previous malignancy/ chemotherapy/ radiotherapy
- •No other serious illness leading to inability to participate in the trial as assessed by the physician.
排除标准
- •1.Non-measurable metastases and primary tumour 2.Major comorbidity factors (unstable angina, myocardial infarction that has occurred within the last 6 months, heart failure ≥2 according to the NYHA classification, uncontrolled high blood pressure 3.Immunocompromised state.
结局指标
主要结局
Progression Free Survival
时间窗: every three monthly till disease progression or death , for upto 2 years
次要结局
- A.Overall survival(B.Overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria)