Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma
NCT ID: NCT06446154
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
36 participants
INTERVENTIONAL
2024-12-27
2026-07-01
Brief Summary
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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
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fruquintinib
Fruquintinib monotherapy
Fruquintinib
Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
Interventions
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Fruquintinib
Fruquintinib was given orally for 5mg/ days. After 3 weeks, the drug was stopped for 1 week.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Shi Ming
Clinical Professor
Locations
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Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Ming Shi
Role: primary
Other Identifiers
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FRU-001
Identifier Type: -
Identifier Source: org_study_id