NCT05971199

Phase II Study of Fruquintinib Combined With Sintilimab and TACE for Inoperable Primary Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, interventional clinical trial is to evaluation of fruquintinib in combination with sintulimab and TACE for inoperable primary hepatocellular carcinoma for progression-free survival (PFS).

Detailed description

Hepatocellular carcinoma (HCC) is the second most common cause of cancer death worldwide, accounting for approximately 745,000 deaths annually and 9.1% of all cancer-related deaths worldwide, with only about 30% of HCC patients having access to curative therapies. Most patients have intermediate to advanced disease and are usually treated with palliative therapy using TACE or systemic therapy (e.g., sorafenib, lenvatinib). The efficacy of either sorafenib or lenvatinib as a single agent in the treatment of hepatocellular liver cancer remains limited, therefore, exploring combination therapy is one of the current research hotspots. A recent randomized, open, multicenter clinical study (TACTICS) enrolling patients with unresectable HCC showed that PFS was significantly prolonged to 25.2 months in the TACE combined with sorafenib treatment group, compared to 25.2 months in the TACE alone group. PFS was only 13.5 months in the TACE treatment group (HR=0. 59, 95%CI: 0.41-0. 87, P=0. 006). Median TTP was 24.1 months in the combination treatment group and 13.5 months in the TACE treatment group alone (HR=0. 56, 95%CL 0. 38-0. 83, P=0. 004). Sintilimab, a recombinant fully human IgG4-type PD-1 monoclonal antibody, is an innovative drug developed by Sintilimab (Suzhou) Co. At the end of 2018, Sintilimab was officially approved by the NMPA of china for the treatment of relapsed or refractory classic Hodgkin's lymphoma (cHL) after at least second-line systemic chemotherapy. As a biosimilar to pembrolizumab, sintilimab has great potential to play a role similar to that played by pembrolizumab in primary hepatocellular carcinoma. Fruquintinib is a potent small molecule VEGFR inhibitor developed by Hutchmed Ltd. with full intellectual property rights, with high kinase selectivity and inhibitory activity only for the VEGFR kinase family (VEGFR1, 2 and 3).On September 5, 2018, the NMPA of china officially approved fruquintinib for patients who have previously received fluorouracil-based, oxaliplatin and irinotecan-based chemotherapy, and for patients with metastatic colorectal cancer (mCRC) who have received prior or are not suitable for prior anti-vascular endothelial growth factor (VEGF) therapy, anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type). Therefore, based on previous studies, this study intended to select patients with unresectable primary hepatocellular carcinoma, and prospectively observe the efficacy and safety of fruquintinib in combination with sintilimab and TACE in the treatment of unresectable CNLC(China liver cancer staging) 2b-3a patients.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib:5 mg capsule orally once daily on day 1-21 in 28-day cycles；
DRUG	Sintilimab	Sintilimab: 200 mg i.v. every 3 weeks
DEVICE	Transcatheter arterial chemoembolization（TACE）	Transcatheter arterial chemoembolization（TACE）

Timeline

• Start date: 2021-11-23
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2023-08-02
• Last updated: 2023-08-02

Locations

1 site across 1 country: China