Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05613478
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Camrelizumab — DRUG
    Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
  • Apatinib Mesylate — DRUG
    Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
  • Radical surgery — PROCEDURE
    Radical surgery
  • Preoperative TACE treatment — PROCEDURE
    TACE treatment before preoperative camrelizumab combined with apatinib mesylate
  • Camrelizumab — DRUG
    Camrelizumab is administered at 200mg, q3w (at least 6 cycles) after radical surgery
  • Apatinib Mesylate — DRUG
    Apatinib Mesylate is administered at 250mg, qd (at least 6 cycles) after radical surgery

Study Details

Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.

Key Dates

Start date
Jan 31, 2023
Status verified
Dec 2024
Primary completion
Nov 1, 2025
Completion
Nov 1, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Preoperative TACE treatment → preoperative camrelizumab combined with apatinib mesylate (q2w, 2 cycles) → radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)
  • Active Comparator: Control group
    Radical surgery → sequential camrelizumab and apatinib mesylate (q3w, at least 6 cycles)

Primary Outcome Measure

2 year event-free survival（2y-EFS） [ Time Frame: 2-year ]

Central Contacts

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