NCT04027764

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

July 17, 2019

Last Update Submit

July 18, 2019

Conditions

Advanced Biliary Tract Cancer

Keywords

advanced biliary tract cancerAlbumin Paclitaxels1Toripalimab

Outcome Measures

Primary Outcomes (1)

  • objective response rate

    ORR

    1 year

Secondary Outcomes (3)

  • progression free survival

    1 year

  • disease response rate

    1 year

  • overall survival

    1 year

Study Arms (1)

Toripalimab Combined With S1 and Albumin Paclitaxel

EXPERIMENTAL
Drug: Toripalimab Combined With S1 and Albumin Paclitaxel

Interventions

Toripalimab Combined With S1 and Albumin PaclitaxelDRUG

Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \\8

Also known as: TSA
Toripalimab Combined With S1 and Albumin Paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Interventions

S 1 (combination)theasinensin A

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor,deputy cheif of oncology department

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 22, 2019

Study Start

May 1, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)