New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Collaborators: Affiliated Hospital of Qinghai University; Air Force Military Medical University, China; Capital Medical University; China Medical University, China; Daping Hospital and the Research Institute of Surgery of the Third Military Medical University; Eastern Hepatobiliary Surgery Hospital; First Affiliated Hospital of Chongqing Medical University; First People's Hospital of Kunming; Fourth Military Medical University; Jilin University; LanZhou University; Peking University First Hospital; Qilu Hospital; Qilu Hospital of Shandong University; Qinghai People's Hospital; Qinghai University; Shandong Provincial Hospital; Shanghai Changzheng Hospital; Shengjing Hospital; Southwest Hospital, China; Tang-Du Hospital; The First Affiliated Hospital of Dalian Medical University; The First Affiliated Hospital of Kunming Medical College; The first clinical college of harbin medical university; The first people's hospital of Guiyang; The first people’s hospital of Guiyang; The people's hospital of Heilongjiang province; The people’s hospital of Heilongjiang province; The Second Affiliated Hospital of Harbin Medical University; Tianjin Medical University Cancer Institute and Hospital; Xi'an Central Hospital; Xuanwu Hospital, Beijing
• Treatments: Cisplatin; Epirubicin; Fluorouracil; Leucovorin; Somatostatin

Criteria

Inclusion Criteria:

1. Patients with unresectable locally advanced disease or unresectable local recurrence, including:

• Patients with unresectable advanced gallbladder cancer （≥ Nevin staging IV or TNM（ tumor node metastasis） classification）

• Patients with complication who have no indication for surgery

• Patients with unresectable local recurrence lesions

2. Age between 18-75, no gender-based constraints

3. Estimated life expectancy ≥12 weeks

4. KPS（Karnofsky performance status ）≥60

5. Each patient gave written informed consent

6. < 2 previous chemotherapy regimes

7. No chemotherapy done in the last 4 weeks

8. Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count > 3,000/mm3 ;Platelet >100,000/mm3 Total bilirubin <5.0mg/dl ALT（alanine transaminase）、 AST（aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN（blood urea nitrogen）≤ 2 times upper limit of normal; serum creatinine <1.5mg/dl: creatinine clearance rate < 60 ml/min

9. Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound

10. Jaundice should be reduced to standard level before chemotherapy (Total bilirubin <5.0 mg/dl)

Exclusion Criteria:

1. Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy

2. Patients who are pregnant or breastfeeding.

3. Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy

4. Patients who had a history of previous carcinoma in the last 5 years.

5. Patients who are allergic to somatostatin or fluorouracil

6. Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.