Gemcitabine-cisplatin-albumin bound paclitaxel (GAP) versus gemcitabine-platinum (GP) in advanced gallbladder cancers (GBC) - a randomized parallel design phase III clinical trial (GAP-GB) - GAP-GB STUDY

Tata Memorial Centre0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

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•Histologically confirmed adenocarcinoma of the gallbladder with the following specifications
•1. Locally advanced unresectable or metastatic on radiology
•2. Age more than 18 years
•3. ECOG performance status 0-2
•4. Patient who can give informed consent for the study.
•5. Patient does not have any contraindications to receive chemotherapy
•6. Adequate Hematological, hepatic and renal function parameters
•7. ECG within acceptable limits
•8. Women of childbearing 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. Distal cholangiocarcinoma,intrahepatic or perihilar cholangiocarcinomas
•2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, oxaliplatin,albumin bound paclitaxel and carboplatin
•3. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure,NYHA III to IV, clinically significant valvular defect
•4. Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix
•5. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
•6. Other severe internal disease or acute infection
•7. Baseline neuropathy more than NCI Grade I
•8. Chronic inflammatory bowel disease
•9. On treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
•10. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
•11. Patients who have completed adjuvant Gem or Platinum based chemotherapy within 6 months.
•12. Received any prior chemotherapy or radiotherapy or cancer directed therapy within the last 5 years (excepting as adjuvant therapy as indicated prior)
•13. Any active ILD or history of lung illness requiring bronchodilator drugs

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