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The DoHAICs Study Expansion Phase

NCT07584018 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-13

No results posted yet for this study

Summary

We explored the efficacy and safety of the first-line treatment of unresectable hepatocellular carcinoma with donafenib combined with hepatic artery infusion chemotherapy (HAIC) and sintilimab .

Conditions

  • HCC - Hepatocellular Carcinoma

Interventions

DRUG

Donafenib

Donafenib (200 mg twice daily, taken orally, initiated 3-7 days before the first HAIC session)

DRUG

sintilimab

sintilimab (200 mg intravenously every 3 weeks, administered 0-1 day before each HAIC treatment)

PROCEDURE

HAIC

HAIC (oxaliplatin 85 mg/m2 over 2 hours, leucovorin 400 mg/m2 over 2 hours, bolus fluorouracil 400 mg/m2 within the first 10 minutes, followed by fluorouracil infusion 1200 mg/m2 over 23 hours, every 3 weeks.)

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-05-20
Primary Completion
2027-06-01
Completion
2027-06-01

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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 NCT07584018 on ClinicalTrials.gov