Donafenib Plus Sintilimab for Advanced HCC

Second Affiliated Hospital of Guangzhou Medical University

Status and phase: Completed; Phase 2

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Donafenib+sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT05162352

MIIR-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Donafenib+sintilimab

Experimental group

Description:

Donafenib combined with sitilimab.

Treatment:

Drug: Donafenib+sintilimab