Comparing two treatments for advanced liver cancer
Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib and Toripalimab Versus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Phase 3, Randomized Controlled and Double-blind Trial
This study is testing if a combination of two treatments for advanced liver cancer can help patients live longer and respond better than just one of the treatments alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | toripalimab, lenvatinib, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06201065 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of hepatic arterial infusion chemotherapy combined with lenvatinib and toripalimab against the same chemotherapy combined with lenvatinib alone in patients with advanced hepatocellular carcinoma. The study is based on previous findings that suggested potential survival benefits from the combination treatment. Participants will be monitored for tumor response and overall survival rates. The trial is designed as a randomized controlled and double-blind study to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with advanced hepatocellular carcinoma who have not received prior treatment and meet specific health criteria.
Not a fit: Patients with cirrhosis beyond Child-Pugh class A or those who are amenable to surgical resection or local ablative therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced hepatocellular carcinoma.
How similar studies have performed: While previous studies have explored similar treatment combinations, this specific approach is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL) * Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria. * Barcelona clinic liver cancer-stage C * Eastern Cooperative Oncology Group performance status of 0 to 2 * With no previous treatment * No Cirrhosis or cirrhotic status of Child-Pugh class A only * Not amendable to surgical resection ,local ablative therapy and any other cured treatment. * This study did not limit HBV DNA load. High HBV-DNA load was aollowed, but hepatitis-B patient must receive concurrent antiviral therapy. * The following laboratory parameters: Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 • Ability to understand the protocol and to agree to and sign a written informed consent document Exclusion Criteria: * Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * Known history of HIV * History of organ allograft * Known or suspected allergy to the investigational agents or any agent given in association with this trial. * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Evidence of bleeding diathesis. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * Known central nervous system tumors including metastatic brain disease
Where this trial is running
Guangzhou, Guangdong
- Cancer Center Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.