The DoHAICs Study Expansion Phase

NCT07584018 | Not Yet Recruiting Phase 2

• 1 other identifier: E20251318
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hepatocellular carcinoma;; Hepatic artery infusion chemotherapy; Surgical resection

Outcome Measures

Primary Outcomes (1)

• event-free survival

  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

Study Arms (1)

Donafenib combined with hepatic artery infusion chemotherapy and sintilimab

EXPERIMENTAL

Donafenib combined with hepatic artery infusion chemotherapy and sintilimab injection as the first-line treatment for unresectable hepatocellular carcinoma

Drug: Donafenib; Drug: sintilimab; Procedure: HAIC

Interventions

Donafenib DRUG

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

Donafenib combined with hepatic artery infusion chemotherapy and sintilimab

sintilimab DRUG

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

Donafenib combined with hepatic artery infusion chemotherapy and sintilimab

HAIC PROCEDURE

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.)

Donafenib combined with hepatic artery infusion chemotherapy and sintilimab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No prior systemic therapy for advanced disease. Patients who received adjuvant chemotherapy following local therapy are eligible if chemotherapy was completed \>12 months ago and disease progression or metastasis has occurred.
• Completion of the last interventional therapy, radiotherapy, or ablation therapy \>4 weeks prior.
• For patients with prior hepatectomy, resection must have been R0, and tumor recurrence must have occurred more than 24 months after surgery.
• At least one measurable lesion as defined by RECIST 1.1 criteria.
• Life expectancy ≥3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• Child-Pugh score ≤7.
• Able and willing to comply with the protocol for the observation of adverse events and efficacy.
• Adequate organ function, defined as meeting the following criteria:
• Hematological function (without transfusion or granulocyte colony-stimulating factor \[G-CSF\] support within 14 days prior to screening):
• Hemoglobin ≥90 g/L.

You may not qualify if:

• Histologically/cytologically confirmed components such as fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma.
• History of malignancies other than hepatocellular carcinoma, except under the following circumstances:
• 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.
• History of hepatic encephalopathy, hepatorenal syndrome, or liver transplantation.
• Clinically symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage.
• Central nervous system metastases.
• History of severe psychiatric illness.
• Diseases affecting the absorption, distribution, metabolism, or excretion of the investigational drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, malabsorption, etc.).
• Prior allogeneic stem cell or solid organ transplantation.
• Prior treatment with anti-VEGF/VEGFR, RAF, MEK pathway targeted therapies (e.g., sorafenib, lenvatinib, regorafenib) or immunomodulators (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies).
• Prior other systemic anti-tumor therapy, including Chinese herbal medicine with anti-tumor indications, completed less than 2 weeks before study drug initiation; or patients with adverse events from prior therapy not recovered to ≤ Grade 1 per CTCAE (excluding alopecia and Grade 1/2 neuropathy caused by oxaliplatin).
• Concurrent use of medications known to prolong QTc interval and/or induce Torsades de Pointes (TdP), or medications that affect drug metabolism.
• Past or present congenital or acquired immunodeficiency diseases.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

donafenib; sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: May 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2025-12