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Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

Primary Purpose

Advanced Biliary Tract Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab Combined With S1 and Albumin Paclitaxel
Sponsored by
Dai, Guanghai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Biliary Tract Cancer focused on measuring advanced biliary tract cancer, Albumin Paclitaxel, s1, Toripalimab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toripalimab Combined With S1 and Albumin Paclitaxel

Arm Description

Outcomes

Primary Outcome Measures

objective response rate
ORR

Secondary Outcome Measures

progression free survival
PFS
disease response rate
DCR
overall survival
OS

Full Information

First Posted
July 17, 2019
Last Updated
July 18, 2019
Sponsor
Dai, Guanghai
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1. Study Identification

Unique Protocol Identification Number
NCT04027764
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
May 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dai, Guanghai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Biliary Tract Cancer
Keywords
advanced biliary tract cancer, Albumin Paclitaxel, s1, Toripalimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toripalimab Combined With S1 and Albumin Paclitaxel
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Toripalimab Combined With S1 and Albumin Paclitaxel
Other Intervention Name(s)
TSA
Intervention Description
Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \8
Primary Outcome Measure Information:
Title
objective response rate
Description
ORR
Time Frame
1 year
Secondary Outcome Measure Information:
Title
progression free survival
Description
PFS
Time Frame
1 year
Title
disease response rate
Description
DCR
Time Frame
1 year
Title
overall survival
Description
OS
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guanghai Dai
Phone
13801232381
Email
daigh60@sohu.com
First Name & Middle Initial & Last Name & Degree
niansong qian
Phone
18201166535
Email
18701317301@qq.com
First Name & Middle Initial & Last Name & Degree
Guanghai Dai

12. IPD Sharing Statement

Plan to Share IPD
No

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Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

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