PD-1 Antibody (SHR-1210) Plus Capecitabine in Patients With Intrahepatic Cholangiocarcinoma After Surgery

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Effect of PD-1 Antibody (SHR-1210) Combined With Capecitabine Treatment After Resection of Intrahepatic Cholangiocarcinoma With High Risk of Recurrence : a Phase 2 Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295317
• Other study ID #: B2019-276-01
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Jian Zhou, professor
• Phone: 0086-21-64041990
• Email: zhou.jian[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SHR-1210 is a humanized anti-PD-1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label,single center,non-randomized ,single arm exploratory study . This clinical study is an investigator-initiated clinical trial(IIT) .The objective of this study is to evaluate the efficacy and safety of therapy with anti-PD-1 antibody SHR-1210 plus Capecitabine in patients with Intrahepatic Cholangiocarcinoma After Surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: February 28, 2024
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age:18-75 years, male or femal;

• Intrahepatic Cholangiocarcinoma confirmed by histopathology, R0 resection was classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA with histolgoic grade G3 according to AJCC TNM (8th edition, 2017);

• No extrahepatic metastases;

• preoperative assessment of Child-Pugh A,ECOG Performance Status 0-1;

• Subjects with chronic HBV infection must have HBV-DNA <500 IU / ml;

• Functional indicators of vital organs meet the following requirements: Neutrophils =1.5*109/L; platelets=50*109/L; hemoglobin=90g/l; Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) = 2.5 times ULN,total bilirubin=1.5 ULN; International standardized ratio (INR) =2.3ULN,creatinine =1.5 ULN;

• No tumor recurrence or metastasis was observed.

Exclusion Criteria:

• Pathological diagnosis of hepatocellular carcinoma, mixed liver cancer, hilar bile duct cancer;

• No anti-tumor treatment for Intrahepatic Cholangiocarcinoma, including chemotherapy and topical treatment, before surgery;

• Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation;

• Tumors are not completely removed, or postoperative pathology suggests non-Intrahepatic Cholangiocarcinoma or other malignant components;

• Subjects with any active autoimmune disease or history of autoimmune disease;

• Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;

• Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);

• Received a live vaccine within 4 weeks of the first dose of study medication;

• .Pregnancy or breast feeding;

• Decision of unsuitableness by principal investigator or physician-in- charge.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• PD-1 blocking antibody SHR-1210
PD1 antibody SHR-1210 D1 200 mg every three weeks; Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)
• Capecitabine
Capecitabine 2500mg / m2/ d, 2 times/d for 2 weeks, followed by 1 week of stopping ,Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival	From the date of liver surgery to the date of diagnosis of tumor recurrence	24 months
Secondary	overall survival	From the date of liver surgery to the date of death	24 months
Secondary	the potential side effects		24 months