Combination Therapy of HAIC, Sintilimab and Bevacizumab for Advanced Hepatocellular Carcinoma

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT05617430
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HAIC — DRUG
    Oxaliplatin: 85mg/m2 , Day 1 Leucovorin: 200mg/m2, Day 1 Fluorouracil: 400mg/m2, Day1 and 2400mg/m2 continuous arterial perfusion for 46h. Q3W
  • Sintilimab — DRUG
    200mg IV d1, Q3W
  • Bevacizumab Biosimilar IBI305 — DRUG
    7.5mg/kg IV d1, Q3W

Study Details

This is a single-arm, exploratory study to evaluate the efficacy and safety of HAIC in combination with sintilimab and bevacizumab in the first line treatment of patients with BCLC-C hepatocellular carcinoma.

Key Dates

First listed
Nov 15, 2022
Start date
Nov 2, 2022
Status verified
Nov 2022
Primary completion
Apr 30, 2024
Completion
Jun 30, 2024

Study Design

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

Arms

  • Experimental: HAIC + Sintilimab + Bevacizumab
    HAIC combine with Sintilimab and bevacizumab biosimilar

Primary Outcome Measure

Progression free survival (PFS) per RECIST v1.1 [ Time Frame: From baseline to primary completion date, about 18 months ]

Central Contacts

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