HAIC Combined With Bevacizumab and Toripalimab for Advanced Hepatocellular Carcinama

Sponsor
Sun Yat-sen University
Study ID
NCT04627363
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Hepatic arterial infusion chemotherapy — PROCEDURE
    administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks
  • Bevacizumab — DRUG
    15mg/kg intravenously every 3 weeks
  • Toripalimab — DRUG
    240mg intravenously every 3 weeks

Study Details

This is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with Bevacizumab and Toripalimab as the first-line therapy for advanced HCC.

Key Dates

First listed
Nov 13, 2020
Start date
Jan 1, 2021
Status verified
Nov 2020
Primary completion
Jun 30, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAIC plus Bevacizumab and Toripalimab
    Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 6 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Toripalimab, 240 mg intravenously every 3 weeks. Bevacizumab 15 mg/kg intravenously every 3 weeks.

Primary Outcome Measure

Progression free survival rate at 6 months [ Time Frame: 6 months] ]

Central Contacts

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