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

Phase 3
18 Years
75 Years
Open (Enrolling)
Gallbladder Neoplasms

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Trial Information

A Phase III Study of 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 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 (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,

- Patients with unresectable advanced gallbladder cancer (≥ Nevin staging IV or
TNM T3 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 ≥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, AST ≤ 2.5 times upper limit of
normal BUN≤ 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Evaluation Criteria in Solid Tumors, RECIST,2009 CR and PR

Outcome Time Frame:

6 month

Safety Issue:


Principal Investigator

Zhi-wei Quan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Xinhua hospital affiliated shanghai jiaotong university school of medicine


China: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

June 2015

Related Keywords:

  • Gallbladder Neoplasms
  • gallbladder neoplasmas
  • Gallbladder Neoplasms,Advanced Stage,Chemotherapy,Somatostatin
  • Neoplasms
  • Carcinoma
  • Gallbladder Neoplasms