HAIC Plus A+T for Patients With High-risk HCC: a Single-arm Phase 2 Trial

Sponsor
Sun Yat-sen University
Study ID
NCT05886465
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    1200 mg, iv.drip, Q3W
  • Bevacizumab — DRUG
    15mg/kg, iv.drip, Q3W
  • HAIC with FOLFOX — PROCEDURE
    administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries, Q3W

Study Details

Atezolizumab plus bevacizumab is the first-line treatment for patients with advanced hepatocellular carcinoma. However, the prognosis for high-risk hepatocellular carcinoma is still poor, with a median overall survival of 7.6 months. Hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin is effective in large hepatocellular carcinoma or hepatocellular carcinoma with major portal vein tumor thrombus. Our previous showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab (programmed cell death protein-1 antibody) had a powerful anti-tumor effect for high-risk hepatocellular carcinoma, with a median overall survival of 18 months. Thus, the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus atezolizumab plus bevacizumab for patients with high-risk hepatocellular carcinoma.

Key Dates

Start date
May 24, 2023
Status verified
May 2023
Primary completion
Jun 1, 2024
Completion
Dec 1, 2024

Study Design

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

Arms

  • Experimental: HAIC plus A+T

Primary Outcome Measure

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

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