Donafenib Plus Sintilimab for Advanced HCC

NCT ID: NCT05162352

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-04
• Study Completion Date: 2023-08-31

Brief Summary

This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).

Detailed Description

This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC.

30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa/IIIb) will be enrolled in the study.

Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle.

Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.

Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Donafenib+sintilimab

Donafenib combined with sitilimab.

Group Type: EXPERIMENTAL

Donafenib+sintilimab

Intervention Type: DRUG

Part 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle.

Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.

Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Interventions

Donafenib+sintilimab

Part 1 (Safety Run-in): donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-days cycle.

Part 2: donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.

Donafenib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Sintilimab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
• Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
• Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
• At least one measurable lesion
• Child-Pugh score ≤7
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ and hematologic function
• Life expectancy of at least 3 months

Exclusion Criteria

• Diffuse HCC
• Macrovascular invasion involving the main trunk or inferior vena cava
• Central nervous system metastasis
• History of malignancy other than HCC
• Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
• Uncontrolled ascites
• History of hepatic encephalopathy
• Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC
• History of organ and cell transplantation
• Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab
• Autoimmune disease or immune deficiency
• Severe organ (heart, kidney) dysfunction

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kangshun Zhu, Dr.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

References

Hong X, Guo Y, Shi W, Zhu K, Liang L, Lin L, Chen Y, Zhou J, Huang J, Huang J, Wu Y, Huang W, Cai M. Donafenib combined with sintilimab for advanced hepatocellular carcinoma: a single arm phase II trial. BMC Cancer. 2025 Feb 5;25(1):205. doi: 10.1186/s12885-025-13605-2.

Reference Type: DERIVED

PMID: 39910472 (View on PubMed)

Other Identifiers

MIIR-08

Identifier Type: -

Identifier Source: org_study_id