A two arm randomized open label prospective parallel design superiority Phase II multicentric clinical trial to evaluate the efficacy of a doublet second line chemotherapy versus monotherapy in advanced unresectable or metastatic gall bladder cancer progressing on first line chemotherapy (GB-SELECT) - GB SELECT

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Patient with advanced unresectable or metastatic GBC cancer that is not amenable to curative intent therapy.
•2) Patients should have been treated with palliative intent first line chemotherapy and should have progressed on the same, or stopped 1st line chemotherapy due to poor tolerance, adverse events or other reasons.
•3) Age 18 to 70 years.
•4) ECOG performance status 0, 1.
•5) If the patient has been treated with curative intent therapy, this therapy should have been completed at least 6 months prior to enrolment.
•6) Patient who can give informed consent for the study.
•7) Patient does not have any contraindications to receive chemotherapy
•8) Adequate organ function
•1)Hematological- Hb > 90 g/L, ANC >= 1.5 x 109/L, platelets >= 100 x 109/L.
•2)Liver functions- bilirubin <= 2 x upper limit normal (ULN), AST/ALT/ ALP <= 2.5 x ULN, S. albumin >= 30 g/L
•3)Renal function- Creatinine <= 1.5 ULN, Creatinine clearance > 50 mL/min.
•9) Women of child-bearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

•1) Serious co-morbidities such as, but not limited to severe cardiac failure severe pulmonary compromise or severe and active infections.
•2) History of treatment with 5 FU, Capecitabine or Irinotecan
•3) Patients with active second malignancies, apart from skin cancers and cervical intraepithelial neoplasia. The presence of a curatively treated malignancy for which the patient has completed therapy at least 3 years ago and is now in remission for, is considered acceptable.
•4) Patients on other investigational drugs within the last 30 days.

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