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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: hepatic artery infusion chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 1115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200127
    • Recruiting
    • Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Contact: Hao Feng, MD, PhD; Phone Number: 86 021-68383651; Email: surgeonfeng@live.com
  • Shanghai, China, 200127
    • Recruiting
    • Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
    • Contact: Qiang Xia, MD, PhD; Phone Number: 86 021-68383651; Email: xiaqiang@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 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.; Other Names: HAIC
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	Drug: 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.; Other Names: HAIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Defined as the time from the date of enrollment to the date of any recorded tumor progression or death from any cause.	2 years
Time to Progression (TTP)	Defined as the time from the date of enrollment to the date of any recorded tumor progression.	2 years
adverse events	Incidence and grading of adverse events (AE) and serious adverse events (SAE).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time from the start of patient enrollment to death from any cause.	2 years
Objective Response Rate (ORR)	Defined as the percentage of subjects with the best response of CR or PR among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).	2 years
Disease Control Rate (DCR)	Defined as the percentage of subjects with the best response of CR, PR, or SD among all subjects in the analysis dataset, from the first dose to the first record of disease progression or death from any cause (whichever occurs first), using the response evaluation criteria in solid tumors (RECIST 1.1 and mRECIST standards).	2 years

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: Renji-LY2024-157-b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No