CTRI/2023/10/058358尚未招募2 期
Gemcitabine, Oxaliplatin and Capecitabine in locally advanced unresectable/metastatic gall bladder carcinoma: an investigator-initiated phase 2 trial - nil
CI, AIIMS0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. ECOG PS – 0-2
- •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.
- •4. 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.
- •5. Patients must not have received prior systemic therapy for the current metastatic or locally advanced biliary cancer
- •6. Patient must not have received adjuvant therapy within 6 months prior to registration
- •7. No prior malignancy or dual malignancy
- •8. Patients must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method.
- •9. Must give informed consent before study initiation.
- •10. Absolute neutrophil count (ANC) ? 1,500/mcL (obtained within 28 days prior to registration)
- •11. Platelets ? 100,000/mcL (obtained within 28 days prior to registration)
- •12. Hemoglobin ?8 g/dL (obtained within 28 days prior to registration)
- •13. Serum albumin?2.8 g/dL (obtained within 28 days prior to registration)
- •13. Total bilirubin ? 1.5 x institutional upper limit of normal (IULN) (obtained within 28 days prior to registration)
- •15. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ? 8 x IULN (obtained within 28 days prior to registration)
- •16. Serum creatinine ? IULN OR calculated creatinine clearance ? 60 mL/min (obtained within 28 days prior to registration)
- •17. Neuropathy- no pre-existing history of peripheral neuropathy > grade 1
- •18. No history of previous malignancy/ chemotherapy/ radiotherapy
- •19. 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
研究者
相似试验
进行中（未招募）
1 期
Gemcitabine and Oxaliplatin in the treatment of locally advanced or metastatic transitional cell carcinoma of the urinary tract in patients with impaired renal function and patients who have progressed on a cisplatin-based regimen - GO-80 protocol in TCC urinary tractocally advanced or metastatic transitional cell carcinoma of the urinary tractEUCTR2005-000192-17-GBBarts & The London NHS Trust28
已完成
2 期
Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)gemcitabine refractory advanced biliary tract cancerJPRN-UMIN000003650Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)40
招募中
不适用
A Randomized study comparing Gemcitabine and oxaliplatin vs gemcitabine and capecitabine in patients with unresectable Carcinoma gall bladder with obstructive jaundice after PTBD/stenting (PTBD or ERCP)CTRI/2015/09/006175AIIMS104
进行中（未招募）
1 期
Fase II trial with gemcitabine and oxaliplatin in patients with unknown primary tumours - UPT - unfitTo test the effect of Gemcitabine and axaliplatin in patients with unknown primary tumours and performance 2 or age 66 to 75EUCTR2005-001959-38-DKGedske Daugaard39
撤回
不适用
A Single-arm Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma in KoreaNeoplasmsKCT0005554Samsung Medical Center34