Hepatic Arterial Infusion Combined With Lenvatinib and Camrelizumab for Unresectable Hepatocellular Carcinoma

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT05003700
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hepatic arterial infusion chemotherapy — PROCEDURE
    administration of oxaliplatin and raltitrexed via the tumor feeding arteries every 3 weeks.
  • Lenvatinib — DRUG
    8 mg once daily (QD) oral dosing.
  • Camrelizumab — DRUG
    200mg intravenously every 3 weeks.

Study Details

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin and raltitrexed plus lenvatinib and camrelizumab in patients with unresectable hepatocellular carcinoma (HCC).

Key Dates

Start date
Aug 12, 2021
Status verified
Nov 2024
Primary completion
May 26, 2023
Completion
Jul 4, 2024

Study Design

Enrollment
39 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAIC(RALOX) plus Lenvatinib and Camrelizumab
    Hepatic arterial infusion of oxaliplatin and raltitrexed every 3 weeks. Lenvatinib 8 mg once daily (QD) oral dosing. Camrelizumab 200mg intravenously every 3 weeks.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years) ]

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