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出境医 / 临床实验 / Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer

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

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.

Condition or disease Intervention/treatment Phase
Advanced Biliary Tract Cancer Drug: Toripalimab Combined With S1 and Albumin Paclitaxel Phase 2

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 Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2021
Arms and Interventions
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 Name: TSA
Outcome Measures
Primary Outcome Measures :
  1. objective response rate [ Time Frame: 1 year ]
    ORR


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: 1 year ]
    PFS

  2. disease response rate [ Time Frame: 1 year ]
    DCR

  3. overall survival [ Time Frame: 1 year ]
    OS


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations

Locations
Layout table for location information
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Guanghai Dai    13801232381    daigh60@sohu.com   
Contact: niansong qian    18201166535    18701317301@qq.com   
Principal Investigator: Guanghai Dai         
Sponsors and Collaborators
Dai, Guanghai
Tracking Information
First Submitted Date  ICMJE July 17, 2019
First Posted Date  ICMJE July 22, 2019
Last Update Posted Date July 22, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2019) 		objective response rate [ Time Frame: 1 year ]
ORR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2019)
  • progression free survival [ Time Frame: 1 year ]
    PFS
  • disease response rate [ Time Frame: 1 year ]
    DCR
  • overall survival [ Time Frame: 1 year ]
    OS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Biliary Tract Cancer
Intervention  ICMJE 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 Name: TSA
Study Arms  ICMJE Experimental: Toripalimab Combined With S1 and Albumin Paclitaxel
Intervention: Drug: Toripalimab Combined With S1 and Albumin Paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date May 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027764
Other Study ID Numbers  ICMJE TSA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dai, Guanghai, Chinese PLA General Hospital
Study Sponsor  ICMJE Dai, Guanghai
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese PLA General Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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