drugset / Trial / NCT01053390
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
Phase 3
Completed
216 enrolled
Shanghai Jiao Tong University School of Medicine
Affiliated Hospital of Qinghai University · collabAir Force Military Medical University, China · collabCapital Medical University · collabChina Medical University, China · collabDaping Hospital and the Research Institute of Surgery of the Third Military Medical University · collabEastern Hepatobiliary Surgery Hospital · collabFirst Affiliated Hospital of Chongqing Medical University · collabFirst Affiliated Hospital of Kunming Medical University · collabFirst People's Hospital of Kunming · collabJilin University · collabLanzhou University Second Hospital · collabPeking University First Hospital · collabQilu Hospital of Shandong University · collabQinghai People's Hospital · collabShandong Provincial Hospital · collabShanghai Changzheng Hospital · collabShengjing Hospital · collabSouthwest Hospital, China · collabTang-Du Hospital · collabThe First Affiliated Hospital of Dalian Medical University · collabThe First People's Hospital of Guiyang · collabThe Second Affiliated Hospital of Harbin Medical University · collabThe first clinical college of harbin medical university · collabThe people's hospital of Heilongjiang province · collabTianjin Medical University Cancer Institute and Hospital · collabXi'an Central Hospital · collabXuanwu Hospital, Beijing · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Objective Primary: Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen Secondary: Determine time to progression-free survival and overall survival of patients treated with this regimen. Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Timeline
- Start
- 2009-10
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatostatin | Traditional medicine (herbal / TCM) | 3 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Epirubicin | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |