Targeted Therapy of Advanced Biliary Tract Cancers - A Phase 2 Clinical Study
Phase 2
- Conditions
- Health Condition 1: C221- Intrahepatic bile duct carcinomaHealth Condition 2: C240- Malignant neoplasm of extrahepaticbile ductHealth Condition 3: C23- Malignant neoplasm of gallbladder
- Registration Number
- CTRI/2020/05/025147
- Lead Sponsor
- Armed Forces Medical Research Committee
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Histologically proven cases of adenocarcinoma of gallbladder and Cholangiocarcinoma.
Locally advanced, unresectable or metastatic disease
ECOG Performance status <2
Adequate bone marrow function reflected
Hemoglobin > 8 gm/dl, TLC > 4,000/cumm
(ANC >1,500/cumm), and Platelets >1,00,000/cumm)
Serum creatinine <1.8 mg%
Serum bilirubin < 3 mg%
Liver enzymes (SGOT and SGPT) within 3 times the
upper normal limit
No prior exposure to gemcitabine, Oxaliplatin, cisplatin, capecitabine or radiation therapy
Exclusion Criteria
Women of reproductive age group not practicing
contraception.
Lactating and pregnant women.
History of previous carcinoma in last 5 yrs.
Active hepatitis B, C or HIV infection.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method