Prospective Real-World Study of HAIC With Raltitrexed or 5-Fluorouracil for the Treatment of Hepatocellular Carcinoma

Inclusion Criteria:

• Presence of clinically significant pleural effusion, ascites, or pericardialeffusion that requires repeated treatment (puncture or drainage, etc.);

• History of immunodeficiency, including positive HIV test, or known history ofallogeneic organ transplantation or allogeneic hematopoietic stem celltransplantation;

• Severe cardiovascular and cerebrovascular diseases, including but not limited to,myocardial infarction, severe/unstable angina, congestive heart failure (NYHA heartfunction classification ≥2), clinically significant supraventricular or ventriculararrhythmias requiring drug intervention, aortic aneurysm requiring surgical repair,any arterial thrombosis/embolism events, grade 3 or higher (Common TerminologyCriteria for Adverse Events [CTCAE] 5.0) venous thrombosis/embolism events,transient cerebral ischemic attacks, cerebrovascular accidents;

• Abdominal or tracheoesophageal fistula, gastrointestinal (GI) perforation orintra-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 drugadministration, such as severe pneumonia requiring hospitalization, bacteremia,infectious complications, etc.; active infection requiring intravenousanti-infection treatment within 2 weeks before the first drug administration orfever of unknown cause >38.5℃ (subject to the investigator's judgment, fever causedby the tumor can be enrolled);

• History of another primary malignant tumor, but malignant tumors that have beentreated with curative treatment before the first intervention of the study and haveno known active disease (more than 5 years) and a low potential for recurrence (suchas skin basal cell carcinoma and skin squamous cell carcinoma treated with potentialcurative treatment) are excluded;

• History of gastrointestinal bleeding within 6 months before enrollment, orconditions 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 mayincrease the risk of participating in the study, affect treatment compliance, orinterfere with the study results, and patients judged by the investigator asunsuitable to participate in this study.

Exclusion Criteria:

• The subject requests to terminate study treatment;

• Disease progression occurs, and the investigator judges that continuing studytreatment has no clinical benefit;

• Any clinical adverse event, laboratory test abnormality, or other medical conditionoccurs, making it likely that the subject will no longer benefit from continuedmedication；

• Pregnancy occurs in a female subject;

• There is a significant deviation from the protocol, and the investigator determinesthat 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 studytreatment.