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Combination of Anti-PD-1 Antibody and Chemotherapy for Unresectable Intrahepatic Cholangiocarcinoma

NCT04413734 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-06-04

No results posted yet for this study

Summary

This study is designed to observe and evaluate the safety and the efficacy of the anti-programmed-death-1 antibody (anti-PD-1) Triprilumab in combination with chemotherapy of Gemcitabine PLUS Cisplatin in patients who were advanced intrahepatic cholangiocarcinoma with no chance for primary surgery.

Conditions

  • Intrahepatic Cholangiocarcinoma by AJCC V8 Stage

Interventions

DRUG

Combination therapy

Triprilumab by intravenous infusion accompanying with Gemcitabine plus Cisplatin

DRUG

Mono-chemotherapy

Gemcitabine plus Cisplatin by intravenous infusion

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-04-22
Primary Completion
2022-04-22
Completion
2024-04-22

Countries

  • China

Study Locations

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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 NCT04413734 on ClinicalTrials.gov