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

Advanced Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04027764
• Other study ID #: TSA-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2019
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dai, Guanghai

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective response rate	ORR	1 year
Secondary	progression free survival	PFS	1 year
Secondary	disease response rate	DCR	1 year
Secondary	overall survival	OS	1 year