MedTrace Logo

Hepatic Arterial Infusion of Raltetrexed With Oxaliplatin(SALOX) Versus FOLFOX in Advanced Hepatocellular Carcinoma

NCT05231382 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2022-05-24

No results posted yet for this study

Summary

Hepatic artery infusion chemotherapy (HAIC) have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC).In China, Oxaliplatin combined with 5-fluorouracil is commonly used in continuous hepatic arterial perfusion chemotherapy.But the 5-FU requiring a long infusion and Calcium folate is also needed to sensitize 5-FU. Moreover, 5-FU regimen was associated with a variety of adverse events, which limited its application in HAIC.Compared to 5-fluorouracil, raltetrexed is less toxic, has a stronger anti-tumor effect and can be administered in just two to three hours. However, the comparison of the two drugs in HAIC to treat advanced HCC has not been reported. In this study, we will evaluate the the progression-free survival(PFS)、objective response rate（ORR）、 disease vacancy rate（DCR）、overall survival (OS) and safety in patients with advanced hepatocellular carcinoma (Ad-HCC) who are undergoing hepatic arterial infusion (HAI) of Raltetrexed plus oxaliplatin (SALOX) compared with oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment by designing prospective, multi-center phase III clinical study.

Conditions

Interventions

PROCEDURE

Raltitrexed, oxaliplatin (SALOX) treatment

Hepatic arterial infusion (HAI) of Raltitrexed, oxaliplatin (SALOX) treatment

PROCEDURE

Oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

Hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Zhao, M.D. & Ph.D. · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2024-02-28
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231382 on ClinicalTrials.gov