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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a prospective cohort study aimed at comparing the efficacy and safety of RALOX-HAIC and FOLFOX-HAIC in the treatment of hepatocellular carcinoma. It is planned to enroll 1115 patients with BCLC Stage B or C hepatocellular carcinoma, who will receive FOLFOX-HAIC or RALOX-HAIC treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
RECRUITING
Shanghai
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 1115
Treatments
Other: FOLFOX-HAIC Cohort
Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:~Oxaliplatin 85 mg/m\^2~Leucovorin calcium 400 mg/m\^2~Fluorouracil 400 mg/m\^2 on Day 1, 2400 mg/m\^2 continuous infusion for 46 hours~Arterial infusion, once every 3 weeks
Other: RALOX-HAIC Cohort
Patients in this group received hepatic arterial infusion chemotherapy, with the following protocol:~Oxaliplatin 100 mg/m\^2~Raltitrexed 3 mg/m\^2~Arterial infusion, once every 3 weeks
Related Therapeutic Areas
Sponsors
Leads: RenJi Hospital

This content was sourced from clinicaltrials.gov

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