Actively Recruiting
Fruquintinib as Second-Line Treatment for Unresectable Hepatocellular Carcinoma Previously Treated with Immune Checkpoint Inhibitors A Single-Arm Phase II Study
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
Researchers are evaluating a new second-line treatment option for advanced hepatocellular carcinoma (HCC), a type of liver cancer, in patients who have previously received immune checkpoint inhibitors. This phase II clinical trial focuses on fruquintinib, a drug that inhibits certain receptors involved in blood vessel growth in tumors. Fruquintinib has shown promising antitumor effects in colorectal cancer and, when combined with other treatments, showed encouraging results in advanced HCC patients. Participants will receive fruquintinib orally at a dose of 5 mg daily for three weeks, followed by a one-week break. This treatment cycle may be repeated as part of the study. The trial is designed as a single-arm study, meaning all participants receive the study drug, and its safety and effectiveness as a second-line therapy for unresectable HCC will be assessed. During the study, participants will undergo evaluations including tumor response measurements to determine the objective response rate over two years. Researchers will monitor liver function, blood counts, and heart function to ensure safety. The study includes patients aged 18 years or older with confirmed advanced HCC and good performance status. The goal is to gather data on how well fruquintinib works and how safe it is in this patient group.
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
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen university cancer center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
M
Ming Shi
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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