Donafenib Plus Sintilimab for Advanced HCC

NCT05162352 | Completed Phase 2

• 1 other identifier: MIIR-08
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Donafenib; Sintilimab; TKI; PD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).

  The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.

  18 months

Secondary Outcomes (6)

• Adverse Events (AEs)

  18 months

• PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1

  18 months

• Objective response rate (ORR) assessed by investigators according to mRECIST.

  18 months

• Disease control rate (DCR) assessed by investigators according to mRECIST.

  18 months

• ORR assessed by investigators according to RECIST 1.1.

  18 months

Study Arms (1)

Donafenib+sintilimab

EXPERIMENTAL

Donafenib combined with sitilimab.

Drug: Donafenib+sintilimab

Interventions

Donafenib+sintilimab 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.

Donafenib+sintilimab

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Related Publications (1)

• 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.

  PMID: 39910472 DERIVED

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

Study Officials

• Kangshun Zhu, Dr.

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

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 1, 2021
• First Posted: December 17, 2021
• Study Start: December 4, 2021
• Primary Completion: October 28, 2022
• Study Completion: August 31, 2023
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

CN (1)