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

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04295317

Collaborator

(none)

Enrollment

Location

Arm

42.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intrahepatic Cholangiocarcinoma	Drug: PD-1 blocking antibody SHR-1210 Drug: Capecitabine	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Aug 1, 2020

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined the therapy using Capecitabine and PD-1 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 2500mg / m2, 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)	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) Drug: 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)

Arm

Intervention/Treatment

Experimental: Combined the therapy using Capecitabine and PD-1

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 2500mg / m2, 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)

Drug: PD-1 blocking antibody SHR-1210

Drug: 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)

Outcome Measures

Primary Outcome Measures

recurrence-free survival [24 months]
From the date of liver surgery to the date of diagnosis of tumor recurrence

Secondary Outcome Measures

overall survival [24 months]
From the date of liver surgery to the date of death
the potential side effects [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ≥1.5109/L; platelets≥50109/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.