New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

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

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:

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.