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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат hepatic artery infusion chemotherapy
  HAIC is a regional therapy that takes advantage of the fact that hepatic tumors, particularly hepatocellular carcinoma, predominantly receive their blood supply from the hepatic artery. The procedure typically involves the insertion of a catheter into the hepatic artery, often through a percutaneous approach or during a surgical procedure. FOLFOX (5-fluorouracil, leucovorin combined with oxaliplatin) or RALOX (raltitrexed combined with oxaliplatin) Q3W.

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: 2 years]
• Time to Progression (TTP) [Срок оценки: 2 years]
• adverse events [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: 2 years]
• Objective Response Rate (ORR) [Срок оценки: 2 years]
• Disease Control Rate (DCR) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong Univer — Шанхай
• Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Шанхай

Идентификаторы

NCT: NCT06519578 · Renji-LY2024-157-b

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗