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

NCT06519578 | Recruiting

• 1 other identifier: Renji-LY2024-157-b
• Study Type: interventional
• Target: 1,115
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Overall Survival (OS)

  2 years

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

Study Arms (2)

FOLFOX-HAIC Cohort

OTHER

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

RALOX-HAIC Cohort

OTHER

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

Interventions

hepatic artery infusion chemotherapy DRUG

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.

Also known as: HAIC

FOLFOX-HAIC Cohort; RALOX-HAIC Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (2)

Deparment of Liver Surgery, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)