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HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

NCT05348811 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-06

No results posted yet for this study

Summary

To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC.

Conditions

Interventions

DRUG

HAIC combined with donafenib and sintilimab

HAIC- GEMOX regimen, gemcitabine 1000 mg/m2, oxaliplatin 85mg/m2 (if the maximum tumor diameter \> 10cm, the dose is 130mg/m2), the first day of each cycle (D1), Q3W. The maximum of 6 times. Sintilimab will be given on the first day of each cycle (D1). 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.The longest treatment time is 24 months. Donafenib was taken orally at 0.2 bid on an empty stomach (1 hour before or \> 2 hours after meal) in the morning and evening of each administration day, with an interval of about 12 hours. Donafenib treatment is initiated within 1 to 3 days of each HAIC treatment until toxicity is intolerable, the investigator determines disease progression, death, informed consent is withdrawn, new antitumor therapy is initiated, or treatment is discontinued for any other reason specified in the protocol.

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Gao-Jun Teng · Zhongda Hospital

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
2022-06-13
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05348811 on ClinicalTrials.gov