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HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence | Clinical Trials | Clareo Health

RECRUITINGPHASE2

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence: a Prospective, Multicenter, Randomized Phase II Study

NCT06812039•Fudan University

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of therapy perioperative treatment with HAIC combined with donafenib and sintilimab (group A)/ donafenib combined with sintilimab (group B) compared with direct surgery (group C) in resectable HCC patients who are at high risk for disease recurrence.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Voluntary enrollment with written informed consent obtained
•Age 18 to 75 years (inclusive), regardless of gender
•Histologically or pathologically confirmed previously untreated hepatocellular carcinoma (HCC) or clinically diagnosed previously untreated HCC according to the AASLD guidelines.
•Initial resectable status as assessed by the investigator (expected to achieve R0 resection, sufficient liver remnant volume, and Child-Pugh class A, as per the "Chinese Expert Consensus on Neoadjuvant Therapy for Liver Cancer (2023 Edition)").
•At least one measurable lesion according to mRECIST criteria.
•Tumor burden meets one of the following conditions:
•1. A single tumor with a diameter \> 5 cm;
•2. Multiple tumors with the largest tumor diameter \> 3 cm, with \< 5 tumors in total;
•3. Presence of portal vein tumor thrombus (Vp1-Vp2).
•Liver function: Child-Pugh score of 5-6.
+6 more criteria

Exclusion Criteria

•Patients with distant metastasis.
•Patients with portal vein tumor thrombosis (Vp3-Vp4).
•History of any other malignant tumor within the past 5 years, unless the patient has received potentially curative treatment and there is no evidence of recurrence in the past 5 years. This 5-year time requirement does not apply to patients who have successfully undergone resection for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ.
•History or current presence of congenital or acquired immunodeficiency diseases.
•Active or previously documented autoimmune diseases or inflammatory disorders (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, uveitis, pituitary inflammation, hyperthyroidism or hypothyroidism, asthma requiring bronchodilators for treatment, etc.). Patients with vitiligo or asthma fully resolved in childhood and not requiring intervention as adults may be included.
•History of severe psychiatric disorders.
•Conditions affecting the absorption, distribution, metabolism, or elimination of the study drugs (e.g., severe vomiting, chronic diarrhea, bowel obstruction, malabsorption, etc.).
•Major surgery within 4 weeks prior to enrollment (as defined by the investigator).
•History of allogeneic stem cell or solid organ transplantation (except for corneal transplantation).
•Received other systemic antitumor therapies (including traditional Chinese medicine with antitumor indications) within 2 weeks or 5 half-lives (whichever is longer) prior to study drug administration, or unresolved adverse events related to prior treatments that have not recovered to ≤ CTCAE Grade 1.
+17 more criteria

Locations (3)

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

TianJin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

January 1, 2025

Primary Completion Date

December 31, 2026

Completion Date

January 31, 2028

Last Updated

February 6, 2025

Enrollment

165

ESTIMATED participants

Conditions

Hepato Cellular Carcinoma (HCC)

Interventions

HAIC combined with sintilimab and donafenib

DRUG

Sintilimab and Donafenib

DRUG

Surgery

PROCEDURE

Contacts

Lu Wang, M.D.

CONTACT

86-18121299357 w.lr@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence

Inclusion Criteria

Exclusion Criteria

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