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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Intrahepatic Cholangiocarcinoma
• Intervention / Treatment: Drug: PD-1 blocking antibody SHR-1210; Drug: Capecitabine

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jian Zhou, professor; Phone Number: 0086-21-64041990; Email: zhou.jian@zs-hospital.sh.cn
• Study Contact Backup: Name: Zheng Wang, professor; Phone Number: 0086-21-64041990; Email: wzdoc@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Contact: Jian Zhou, professor; Phone Number: 0086-21-64041990; Email: zhou.jian@zs-hospital.sh.cn
      • Contact: Zheng Wang, professor; Phone Number: 0086-21-64041990; Email: wzdoc@163.com
      • Principal Investigator: Jian Zhou, professor
      • Sub-Investigator: Zheng Wang, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence-free survival	From the date of liver surgery to the date of diagnosis of tumor recurrence	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	From the date of liver surgery to the date of death	24 months
the potential side effects		24 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Jian Zhou, professor, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): August 31, 2022
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (Actual): March 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 26, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Capecitabine; PD-1 Antibody; Adjuvant therapy; Intrahepatic Cholangiocarcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Cholangiocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunologic Factors; Antibodies; Antibodies, Blocking; Capecitabine
• Other Study ID Numbers: B2019-276-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No