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

NCT04295317 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: B2019-276(2)R
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrahepatic Cholangiocarcinoma

Keywords

PD-1 Antibody; Capecitabine; Intrahepatic Cholangiocarcinoma; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• recurrence-free survival

  From the date of enrollment to the date of diagnosis of tumor recurrence

  24 months

Secondary Outcomes (2)

• overall survival

  24 months

• the potential side effects

  24 months

Study Arms (1)

Combined the therapy using Capecitabine and PD-1

EXPERIMENTAL

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

Interventions

PD-1 blocking antibody SHR-1210 DRUG

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)

Combined the therapy using Capecitabine and PD-1

Capecitabine DRUG

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)

Combined the therapy using Capecitabine and PD-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Wang Z, Li L, Huang P, Tu H, Zhang X, Yu L, Liang F, Huang C, Qiu S, Ye Q, Ding Z, Huang X, Shi Y, Song K, Sun H, Wang X, Xu Y, Yu Y, Gao Q, Zhang L, Fan J, Zhou J. Adjuvant camrelizumab combined with capecitabine in patients with intrahepatic cholangiocarcinoma after surgical resection in China (ACC): a single-arm, single-centre, open-label, phase 2 trial. Lancet Gastroenterol Hepatol. 2026 Feb;11(2):124-136. doi: 10.1016/S2468-1253(25)00268-7. Epub 2025 Nov 27.

  PMID: 41319673 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jian Zhou, professor

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: August 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)