New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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

Conditions

• Gallbladder Neoplasms

Interventions

DRUG

Somatostatin

Somatostatin 3mg+NS（normal saline）60ml, a continuous intravenous infusion, q12h

DRUG

epirubicin, cisplatin, LV（Leucovorin）、 5-FU（5-Fluorouracil）

Sponsors & Collaborators

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Capital Medical University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Tianjin Medical University Cancer Institute and Hospital

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• The first clinical college of harbin medical university

  collaborator UNKNOWN

• The Second Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• Jilin University

  collaborator OTHER

• The people's hospital of Heilongjiang province

  collaborator UNKNOWN

• Eastern Hepatobiliary Surgery Hospital

  collaborator OTHER

• Shanghai Changzheng Hospital

  collaborator OTHER

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Qilu Hospital of Shandong University

  collaborator OTHER

• Air Force Military Medical University, China

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• Qinghai People's Hospital

  collaborator OTHER

• Affiliated Hospital of Qinghai University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

  collaborator OTHER

• First People's Hospital of Kunming

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Xi'an Central Hospital

  collaborator OTHER

• The first people's hospital of Guiyang

  collaborator UNKNOWN

• Southwest Hospital, China

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• Shanghai Jiao Tong University School of Medicine

  lead OTHER

Principal Investigators

• Zhi-wei Quan, MD · Xinhua hospital affiliated shanghai jiaotong university school of medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-31

Primary Completion

2013-12-31

Completion

2013-12-31

Countries

• China

Study Locations