A phase II trial of neoadjuvant chemotherapy using the combination of gemcitabine and cisplatin for patients with initially unresectable locally advanced biliary tract cancer.
Phase 2
Recruiting
- Conditions
- Biliary tract cancer (Intrahepatic cholangiocarcinoma, Extrahepatic cholangiocarcinoma, Gallbladder carcinoma)
- Registration Number
- JPRN-UMIN000015330
- Lead Sponsor
- Adjuvant therapy for BTC Research Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pulmonary fibrosis or interstitial pneumonia 2. Severe myelosuppression 3. Pregnant female, possibly pregnant females, females wishing to become pregnant, and females feeding babies. 4. Serious renal dysfunction 5. Serious liver dysfunction 6. Patients with severe allergy 7. History of breast or lung radiation 8. Active infection 9. Patient with uncontrollable pleural effusion and/or severe edema 10. Active double cancer 11. Severe complications including uncontrollable diabetes mellitus. 12. Severe mental disorder 13. Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Resection rate
- Secondary Outcome Measures
Name Time Method 1. Overall survival 2. Disease free survival 3. Progression free survival 4. Tumor response rate 5. Adverse events