Brief Title
Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer
Official Title
Toripalimab Combined With S1 and Albumin Paclitaxel as First Line in Patients With Advanced Biliary Tract Cancer: a Single-arm,One Center， Phase II Clinical Study
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 Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment
continually until disease progression or intolerable toxicity or Patients withdrawal of
consent.and target sample is 30+ patients.
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 cycle
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
objective response rate
Secondary Outcome
progression free survival
Condition
Advanced Biliary Tract Cancer
Intervention
Toripalimab Combined With S1 and Albumin Paclitaxel
Study Arms / Comparison Groups
Toripalimab Combined With S1 and Albumin Paclitaxel
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
May 1, 2019
Completion Date
May 1, 2021
Primary Completion Date
May 1, 2020
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years old
2. Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
3. Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
4. ECOG score 0 or 1 point
5. At least one measurable lesion
6. no previous treatment
Exclusion Criteria:
1. organs failure ,including liver ,heart ,kidney
2. Have received a liver transplant in the past
3. Active brain metastasis or spinal cord compression
4. ECOG score 3 or 4 point
5. Symptomatic peripheral neuropathy (CTCAE ≥ 2)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04027764
Organization ID
TSA-01
Responsible Party
Sponsor-Investigator
Study Sponsor
Dai, Guanghai
Study Sponsor
, ,
Verification Date
July 2019