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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEastern Hepatobiliary Surgery Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Age: Age ≥ 18 years old.

Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.

Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).

Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.

Disqualifiers

Previous treatment: Previously received systemic treatment for ICC.

Poor physical condition: ECOG physical condition score ≥ 2.

Poor liver function: Child Pugh grading>8.

Short life expectancy: Life expectancy is less than 3 months.

Trial design

Treatments tested in this trial

  • PD-L1 inhibitor
  • HAIC

Treatment groups

50 Participants
are divided into 1 treatment group