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

Phase 2

• Conditions: Advanced Biliary Tract Cancer
• Interventions: Drug: Toripalimab Combined With S1 and Albumin Paclitaxel

• Registration Number: NCT04027764
• Lead Sponsor: Dai, Guanghai

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 Timeline

• Study Start: 2019-05-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22
• Primary Completion: 2020-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Toripalimab Combined With S1 and Albumin Paclitaxel	Toripalimab Combined With S1 and Albumin Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
objective response rate	1 year	ORR

Secondary Outcome Measures

Name	Time	Method
progression free survival	1 year	PFS
disease response rate	1 year	DCR
overall survival	1 year	OS

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China