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

July 18, 2019 updated by: Dai, Guanghai

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Principal Investigator:
          • Guanghai Dai
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Toripalimab Combined With S1 and Albumin Paclitaxel
Drug: Toripalimab Combined With S1 and Albumin Paclitaxel
Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \8
Other Names:
  • TSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 1 year
ORR
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: 1 year
PFS
1 year
disease response rate
Time Frame: 1 year
DCR
1 year
overall survival
Time Frame: 1 year
OS
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dai, Guanghai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

July 17, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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