Actively Recruiting
Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma
Led by Sun Yat-sen University · Updated on 2024-12-31
36
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
G
Guangzhou First People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fruquintinib After ICIs Treatment in Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosed with unresectable, locally advanced, or metastatic hepatocellular carcinoma confirmed by histology, cytology, or clinical criteria
- Previously treated with immune checkpoint inhibitors
- Have at least one measurable tumor according to RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Child-Pugh liver function score of 7 or less
- Adequate blood counts and organ function including neutrophil count ≥1.2×10⁹/l, platelet count ≥60×10⁹/l, total bilirubin <30 μmol/l, albumin ≥30 g/l, liver enzymes ≤5 times upper limit normal, creatinine clearance ≤1.5 times upper limit normal, and left ventricular ejection fraction ≥45%
You will not qualify if you...
- History of HIV infection or organ transplant
- Presence of other malignant tumors
- Evidence of liver failure, bleeding disorders, or bleeding events
- Allergy to the study drug or related agents
- Incomplete medical records
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
M
Ming Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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