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Adjuvant PD-1 Antibody in Combination With Capecitabine for Patients With ICC at High-Risk of Postoperative Recurrence

NCT04782804 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-08-18

No results posted yet for this study

Summary

The purpose of the study is to observe the effect of PD-1 Antibody（Tislelizumab） Combined With Capecitabine as Adjuvant Therapy to Prevent the Recurrence in High-risk Patients With Cholangiocarcinoma After Curative Resection.

Conditions

  • Cholangiocarcinoma, Intrahepatic

Interventions

DRUG

Capecitabine

Capecitabine+PD-1 Antibody（Tislelizumab）as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.

DRUG

PD-1 Antibody（Tislelizumab）

PD-1 Antibody（Tislelizumab, 200mg） was given q3w iv.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-12-30
Completion
2024-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782804 on ClinicalTrials.gov