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

NCT ID: NCT04027764

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-05-01

Brief Summary

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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

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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

Conditions

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Advanced Biliary Tract Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Toripalimab Combined With S1 and Albumin Paclitaxel

Group Type EXPERIMENTAL

Toripalimab Combined With S1 and Albumin Paclitaxel

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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TSA

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dai, Guanghai

OTHER

Sponsor Role lead

Responsible Party

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Dai, Guanghai

professor,deputy cheif of oncology department

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Guanghai Dai

Role: primary

13801232381

niansong qian

Role: backup

18201166535

Other Identifiers

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TSA-01

Identifier Type: -

Identifier Source: org_study_id

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