MedTrace Logo

HAIC Combined With Cadonilimab and Regorafenib as 2nd-line Treatment for ICC

NCT06335927 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-03-28

No results posted yet for this study

Summary

This study is a single-arm Phase II clinical trial aiming to evaluate the safety and efficacy of HAIC combined with Cadonilimab and Regorafenib as second-line treatment for unresectable intrahepatic cholangiocarcinoma.

The study plans to enroll approximately 45 participants. All enrolled participants will receive continuous treatment: HAIC-Gemox: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles, Cadonilimab(6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W) until the investigator determines that there is no longer any clinical benefit (based on comprehensive assessment including RECIST v1.1 imaging evaluation and clinical condition), intolerable toxicity, initiation of new anti-tumor therapy, or meeting other criteria for treatment discontinuation, whichever occurs first.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

HAIC-GEMOX+Cadonilimab+Regorafenib

HAIC-GEMOX: Gemcitabine 1000mg/m2 on Day 1 + Oxaliplatin 85mg/m2 on Day 1, every 3 weeks (Q3W), for up to 6 treatment cycles in combination with Cadonilimab (6mg/kg, D2, Q3W) and Regorafenib (80mg QD, Q3W)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2025-05-10
Completion
2026-05-10

Countries

  • China

Study Locations

More Related Trials

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 NCT06335927 on ClinicalTrials.gov