Comparing two chemotherapy methods for liver cancer treatment

Prospective Real-World Study of Hepatic Arterial Infusion Chemotherapy (HAIC) With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma

This study is testing which of two chemotherapy methods works better for people with liver cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1115 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT06519578 on ClinicalTrials.gov

What this trial studies

This study is a prospective cohort analysis that aims to evaluate the efficacy and safety of two different hepatic artery infusion chemotherapy regimens, RALOX-HAIC and FOLFOX-HAIC, in patients with hepatocellular carcinoma. It plans to enroll 1,115 patients diagnosed with BCLC Stage B or C hepatocellular carcinoma, who will receive one of the two treatment options. The study will monitor patient outcomes to determine which method is more effective in managing the disease.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with BCLC Stage B or C hepatocellular carcinoma.

Not a fit: Patients with severe cardiovascular or cerebrovascular diseases, or those with significant gastrointestinal complications 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 hepatocellular carcinoma.

How similar studies have performed: Other studies have explored similar chemotherapy approaches, but the specific combination of RALOX-HAIC and FOLFOX-HAIC in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Presence of clinically significant pleural effusion, ascites, or pericardial effusion that requires repeated treatment (puncture or drainage, etc.);
* History of immunodeficiency, including positive HIV test, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
* Severe cardiovascular and cerebrovascular diseases, including but not limited to, myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heart function classification ≥2), clinically significant supraventricular or ventricular arrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair, any arterial thrombosis/embolism events, grade 3 or higher (Common Terminology Criteria for Adverse Events \[CTCAE\] 5.0) venous thrombosis/embolism events, transient cerebral ischemic attacks, cerebrovascular accidents;
* Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation or intra-abdominal abscess within 6 months before the first study drug administration;
* Severe infection (CTCAE 5.0 \> grade 2) occurred within 28 days before the first drug administration, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active infection requiring intravenous anti-infection treatment within 2 weeks before the first drug administration or fever of unknown cause \>38.5℃ (subject to the investigator's judgment, fever caused by the tumor can be enrolled);
* History of another primary malignant tumor, but malignant tumors that have been treated with curative treatment before the first intervention of the study and have no known active disease (more than 5 years) and a low potential for recurrence (such as skin basal cell carcinoma and skin squamous cell carcinoma treated with potential curative treatment) are excluded;
* History of gastrointestinal bleeding within 6 months before enrollment, or conditions judged by the investigator to have a risk of gastrointestinal bleeding (such as severe esophageal-gastric varices);
* Other severe physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, affect treatment compliance, or interfere with the study results, and patients judged by the investigator as unsuitable to participate in this study.

Exclusion Criteria:

* The subject requests to terminate study treatment;
* Disease progression occurs, and the investigator judges that continuing study treatment has no clinical benefit;
* Any clinical adverse event, laboratory test abnormality, or other medical condition occurs, making it likely that the subject will no longer benefit from continued medication；
* Pregnancy occurs in a female subject;
* There is a significant deviation from the protocol, and the investigator determines that study treatment should be terminated;
* The subject dies or is lost to follow-up;
* The study is terminated;
* Other situations determined by the investigator that require termination of study treatment.

Where this trial is running

Shanghai and 1 other locations

• Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)

Conditions Hepatocellular Carcinoma