Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07364305

HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC

Led by Eastern Hepatobiliary Surgery Hospital · Updated on 2026-01-23

50

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.

CONDITIONS

Official Title

HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with advanced unresectable intrahepatic cholangiocarcinoma (ICC) by histology or imaging
  • At least one measurable tumor lesion according to RECIST 1.1 criteria
  • Eastern Cancer Collaboration Group (ECOG) physical fitness status score of 0 or 1
  • Expected lifespan of 3 months or more
  • Liver function classified as Child Pugh A or B
  • Sufficient organ function and laboratory tests meeting protocol requirements
  • Not currently receiving systemic treatment for ICC
Not Eligible

You will not qualify if you...

  • Previously received systemic treatment for ICC
  • ECOG physical condition score of 2 or higher
  • Liver function Child Pugh grading greater than 8
  • Life expectancy less than 3 months
  • Having other malignant tumors or a history of other malignant tumors
  • Severe dysfunction in organs such as heart, brain, lungs, or kidneys
  • Allergy or intolerance to the investigational drug or its components
  • Other conditions deemed unsuitable for participation by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China, 200438

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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