Modified TOMOX-HAIC in Combination With Sintilimab and Bevacizumab Biosimilar for First-line Treatment of Advanced Hepatocellular Carcinoma

Sponsor
Fudan University
Study ID
NCT06285019
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • TOMOX-HAIC — PROCEDURE
    Oxaliplatin 85mg/m\^2 plus Raltitrexed 3mg/m\^2, 21 days for a cycle
  • Sintilimab — DRUG
    200mg, ivgtt, d1, 21 days for a cycle
  • Bevacizumab — DRUG
    7.5mg/kg, ivgtt, d1, 21 days for a cycle

Study Details

This is a single-center, single-arm, phase II clinical study, to explore the efficacy and safety of modified TOMOX-HAIC combined with sintilimab and bevacizumab biosimilar as first line treatment in patients with advanced hepatocellular carcinoma.

Key Dates

First listed
Feb 29, 2024
Start date
Dec 1, 2023
Status verified
Feb 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Combination therapy
    TOMOX-HAIC combined with Sintilimab and bevacizumab biosimilar

Primary Outcome Measure

objective response rate (ORR) [ Time Frame: 24 months ]

Central Contacts

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