Status:
UNKNOWN
Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer
Lead Sponsor:
Dai, Guanghai
Conditions:
Advanced Biliary Tract Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclita...
Detailed Description
Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cyc...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
- Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
- ECOG score 0 or 1 point
- At least one measurable lesion
- no previous treatment
Exclusion
- organs failure ,including liver ,heart ,kidney
- Have received a liver transplant in the past
- Active brain metastasis or spinal cord compression
- ECOG score 3 or 4 point
- Symptomatic peripheral neuropathy (CTCAE ≥ 2)
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04027764
Start Date
May 1 2019
End Date
May 1 2021
Last Update
July 22 2019
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853