Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma

NCT06446154 | Recruiting Phase 2

• 1 other identifier: FRU-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Immune Checkpoint Inhibitors; Anti-angiogenic Therapy; Second-line Treatment

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective response rate

  Two years

Secondary Outcomes (2)

• OS

  Two years

• PFS

  Two years

Study Arms (1)

Fruquintinib

EXPERIMENTAL

Fruquintinib monotherapy

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.

Fruquintinib

Eligibility Criteria

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

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangzhou First People's Hospital: collaborator

Study Sites (1)

Sun Yat-sen university cancer center

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

HMPL-013

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

Central Study Contacts

Ming Shi

CONTACT

020-87343115; shiming@sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Fruquintinib

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 6, 2024
• Study Start: December 27, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)