The DoHAICs Study Expansion Phase

ConditionHCC - Hepatocellular Carcinoma

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the trial and provide written informed consent.

Age between 18 and 80 years (inclusive), regardless of gender.

Patients with hepatocellular carcinoma (HCC) clinically diagnosed per the "Standard for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)" or confirmed by histology/cytology.

Patients with inoperable or metastatic hepatocellular carcinoma.

Disqualifiers

Histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.

The patient has undergone potentially curative treatment with no evidence of that disease for 5 years.

Successfully resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, or other carcinoma in situ.

Diffuse tumor lesions.

Trial design

Design model

Single group

Treatments tested in this trial

Donafenib
Drug
Donafenib (200 mg twice daily, taken orally, initiated 3-7 days before the first HAIC session)
sintilimab
Drug
sintilimab (200 mg intravenously every 3 weeks, administered 0-1 day before each HAIC treatment)
HAIC
Procedure/Surgery
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.)

Treatment groups

90 Participants

are divided into 1 treatment group

Group A: Donafenib combined with hepatic artery infusion chemotherapy and sintilimabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

event-free survival

Time frame

The time from enrollment to the date of first documented progression, recurrence, or death from any cause, whichever came first, assessed up to 36 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: