New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

Study Design: Treatment, Randomized, Open Label, controlled,Multicenter Group Assignment, Safety/Efficacy Study

Chemotherapy regimen:

Group A: Conventional chemotherapy regimen Group B: New chemotherapy regimen: conventional regimen plus SST（somatostatin） Cycles repeat every 4 weeks and 6 cycles in total

Patients: A total of 260 patients (130 per group) will be accrued for this study.

Patients distribution:

10patients per center are enrolled in the study and 30 centers (hospitals) in total which meet the total number of patients in trial.

Clinical Outcome Assessments:

Primary: the objective response rate (response evaluation criteria in solid tumors ,RECIST criteria) Secondary: progression-free survival, overall survival, quality of life，the adverse event

Safety Assessments:

Physical exam, laboratory test, probably occurred adverse event.

Inclusion criteria

• 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
• Age between 18-75, no gender-based constraints
• Estimated life expectancy ≥12 weeks
• KPS（Karnofsky performance status ）≥60
• Each patient gave written informed consent
• < 2 previous chemotherapy regimes
• No chemotherapy done in the last 4 weeks
• 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
• Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound
• Jaundice should be reduced to standard level before chemotherapy (Total bilirubin <5.0 mg/dl)

Exclusion criteria

• Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy
• Patients who are pregnant or breastfeeding.
• Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy
• Patients who had a history of previous carcinoma in the last 5 years.
• Patients who are allergic to somatostatin or fluorouracil
• Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.