SHR-1210 Combined With Apatinib Mesylate in the Perioperative Therapy for Hepatocellular Carcinoma

Sponsor
Zhejiang University
Study ID
NCT04930315
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Apatinib Mesylate — DRUG
    250mg, po, qd, q2w in neoadjuvant and adjuvant group, before surgery
  • Camrelizumab — DRUG
    200mg, iv, d1, q2w, both in two groups

Study Details

The purpose of this study was to compare the efficacy and safety of camrelizumab + apatinib mesylate neoadjuvant therapy combined with camrelizumab adjuvant therapy and camrelizumab adjuvant therapy alone in patients with technically resectable hepatocellular carcinoma.

Key Dates

Start date
Sep 15, 2021
Status verified
Jun 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

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

Arms

  • Experimental: neoadjuvant and adjuvant group
    Preoperative：Camrelizumab ：200mg, iv, d1, q2w, 4 cycles；apatinib：250mg, po, qd, q2w, 3 cycles Operation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 8 cycles
  • Active Comparator: adjuvant group
    Operation Postoperation 4-8 weeks，Camrelizumab ：200mg, iv, d1, q2w, Up to 12 cycles

Primary Outcome Measure

1-year tumor recurrence-free rate [ Time Frame: Up to one years ]

Central Contacts

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