The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus TACE or HAIC as First-line Treatment for Unresectable Hepatocellular Carcinoma A Multi-center, Retrospective Clinical Study

NCT07724951 | Not Yet Recruiting

• 1 other identifier: B2026-120
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 8

Brief Summary

This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• progression free survival(PFS)

  Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors

  Up to approximately 2 year

Secondary Outcomes (5)

• Objective response rate（ORR）

  up to approximately 2 years

• Disease control rate（DCR）

  up to approximately 2 years

• Overall Survival (OS）

  up to approximately 2 years

• Duration of Response（DOR）

  up to approximately 2 years

• Safety（incidence of AEs ）

  up to approximately 2 years

Study Arms (2)

Group A

Donafenib +PD-1/L1+TACE

Drug: Donafeinib; Procedure: Transcatheter arterial chemoembolization; Drug: PD-1 / PD-L1 monoclonal antibody

GROUP B

Donafenib +PD-1/L1+HAIC

Drug: Donafeinib; Drug: PD-1 / PD-L1 monoclonal antibody; Procedure: Hepatic Artery Infusion Chemotherapy

Interventions

Donafeinib DRUG

Donafenib: 200mg Bid, or follow medical order

GROUP B; Group A

PD-1 / PD-L1 monoclonal antibody DRUG

Follow Drug instructions or medical order

GROUP B; Group A

Hepatic Artery Infusion Chemotherapy PROCEDURE

Follow medical orders

GROUP B

Transcatheter arterial chemoembolization PROCEDURE

Follow medical order

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy (TACE or HAIC) as first line treatment.

You may qualify if:

• Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30, 2024.
• Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology.
• Age ≥18 years, regardless of sex.
• No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC).
• The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression.
• For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery.
• At least one evaluable lesion (according to RECIST v1.1 criteria).
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 1.
• Child-Pugh class A or B.
• Adequate major organ function, defined by the following criteria:
• Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor \[G-CSF\] within 14 days prior to screening):
• Hemoglobin ≥90 g/L;
• Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
• Platelet count ≥75×10⁹/L;
• \- Blood biochemistry (without albumin use within 14 days prior to screening):

You may not qualify if:

• Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up;
• Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month;
• Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components;
• History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Yunnan Cancer Hospital: collaborator

Study Sites (8)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Zhong Shan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Location

Yunnan Cancer Hospital

Kunming, Yunan, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Central Study Contacts

Zheng Wang

CONTACT

+86 021 6404 1990; wang.zheng@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)