HAIC Combined With Camrelizumab and TKI for Unresectable Hepatocellular Carcinoma After TACE Failure

Sponsor
Yue Han
Study ID
NCT05135364
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Each infusion is 30 min (not less than 20 min, not more than 60 min), once every 3 weeks
  • HAIC — DRUG
    A chemotherapy regimen perfused through the tumor supplying artery, d1-2 administration, perfused every 4 weeks
  • TKI — DRUG
    Lenvatinib or Regorafenib

Study Details

The efficacy and safety of HAIC combined with tyrosine kinase inhibitor and immunotherapy have been proved by the clinical research. In this single-arm, open-label, prospective study, for those patients with unresectable primary HCC, in the case of failure of TACE treatment, the combination of HAIC, TKI and immunotherapy is expected to bring new breakthroughs.

Key Dates

Start date
Nov 5, 2021
Status verified
Nov 2021
Primary completion
Oct 5, 2022
Completion
Dec 5, 2024

Study Design

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

Arms

  • Experimental: Camrelizumab+HAIC+TKI*
    \*For patients who have not received molecular targeted therapy in the past, lenvatinib is recommended; For patients who have received sorafenib or lenvatinib in the past, regorafenib is recommended.

Primary Outcome Measure

Progression-free survival (according to mRECIST) [ Time Frame: Up to two years ]

Central Contacts

Related Studies