Comparing two treatments for liver cancer with portal vein tumor thrombus

Hepatic Arterial Infusion Chemotherapy Plus Toripalimab Versus Hepatic Arterial Infusion Chemotherapy Plus Sorafenib for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Non-comparative, Prospective, Randomized Trial

This study is testing whether adding a new drug called toripalimab to a chemotherapy treatment can help people with liver cancer that has spread to the portal vein feel better compared to the standard treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: toripalimab, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04135690 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) combined with either toripalimab or sorafenib in patients with hepatocellular carcinoma (HCC) that has spread to the portal vein. The trial is designed as a prospective, randomized, non-comparative study, building on previous findings that suggested HAIC with sorafenib was more effective than sorafenib alone. The study aims to determine if adding toripalimab enhances treatment outcomes compared to the established combination. Participants will receive either treatment and be monitored for efficacy and safety outcomes.

Who should consider this trial

Good fit: Ideal candidates include patients diagnosed with hepatocellular carcinoma with portal vein tumor thrombus who have not received prior treatment.

Not a fit: Patients with cirrhosis beyond Child-Pugh class A or those who are amendable 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 liver cancer and portal vein tumor thrombus.

How similar studies have performed: Previous studies have shown that HAIC combined with sorafenib is effective, but this specific comparison with toripalimab is novel.

Eligibility 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.
* Patients with portal vein tumor thrombus
* 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.
* The following laboratory parameters:

Platelet ≥75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 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)

Study contacts

• Study coordinator: Ming Shi, MD

Conditions Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy; Oxaliplatin, 5-Fluorouracil and Leucovorin; Toripalimab; Sorafenib