Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma; Immune Checkpoint Inhibitors; Anti-angiogenic Therapy; Second-line Treatment
• Interventions: Drug: Fruquintinib

• Registration Number: NCT06446154
• Lead Sponsor: Sun Yat-sen University

Brief Summary

Nowadays, there are few second-line treatment options for advanced hepatocellular carcinoma (HCC). In order to further improve the efficacy of second-line treatment for advanced HCC, we plan to conduct a phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC.

As a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor -1/2/3 (VEGFR 1/2/3), fruquintinib had demonstrated a strong antitumor efficacy in colorectal cancer patients who had previously received standard chemotherapy. Compared with placebo, fuquinitinib significantly extended overall survival in patients with metastatic colorectal cancer (median OS, 9.3 months vs 6.6 months; HR, 0.65; p\<0.001) and progression-free survival (median PFS, 3.7 months vs 1.8 months; HR, 0.26; p\<0.001). Additionally, a phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment, with a median PFS of 7.4 months and a tumor response rate of 31.6%.

Therefore, we intend to conduct this clinical study to explore the efficacy and safety of fruquintinib as second-line treatment for patients with unresectable HCC previously treated with immune checkpoint inhibitors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-06-04
• Study First Posted: 2024-06-06
• Status Verified: 2024-12
• Study Start: 2024-12-27
• Last Update Submitted: 2024-12-29
• Last Update Posted: 2024-12-31
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients aged 18 years or older
• with unresectable, locally advanced, or metastatic HCC, with the diagnosis confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Disease criteria
• who had previously received immune checkpoint inhibitors
• had at least on measurable disease, as defined by Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1) criteria
• had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• had a Child-Pugh liver function score of 7 or less
• had adequate hematologic and organ function (absolute neutrophil count ≥1.2×109/l, platelet count ≥60×109/l, total bilirubin < 30μmol/l, albumin ≥ 30g/l, aspartate transaminase and alanine transaminase ≤ 5×upper limit of the normal, creatinine clearance rate of ≤ 1.5×upper limit of the normal, and left ventricular ejection ≥ 45%)

Exclusion Criteria

• history of HIV, organ allograft
• combined with other malignant tumors
• evidence of hepatic decompensation, bleeding diathesis or event
• allergy to the investigational agents or any agent given in association with this trial
• incomplete medical information.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fruquintinib	Fruquintinib	Fruquintinib monotherapy

Primary Outcome Measures

Name	Time	Method
ORR	Two years	Objective response rate

Secondary Outcome Measures

Name	Time	Method
OS	Two years	Median overall survival
PFS	Two years	Median progression-free survival

Trial Locations

Locations (1)

Sun Yat-sen university cancer center; 🇨🇳 Guangzhou, Guangdong, China