mFOLFOX7 Plus Camrelizumab and Apatinib for Advanced HCC

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05412589
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stage III Hepatocellular Cancer (CNLC Staging)

Eligibility Criteria

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

Interventions

  • mFOLFOX7+Camrelizumab+Apatinib — DRUG
    Drug: Leucovorin 200mg/m2 administered IV on Days 1 of a 21 day cycle Drug: Oxaliplatin 85 mg/m2 IV on Days 1 of a 21 day cycle. Drug: Fluorouracil 5-FU continuous infusion: 400mg/m2 on D1 and then 2400mg/m2 for 46h of each 21 day cycle. Drug: Camrelizumab 200mg infusion on D1 for every 21 days Drug: Apatinib 250mg，po，qd for every 21 days

Study Details

This is a prospective, one-arm, phase II clinical study of intravenous mFOLFOX6 plus Camrelizumab combined with apatinib for CNLC stage III hepatocellular carcinoma

Key Dates

Start date
Jun 10, 2022
Status verified
Jul 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: intravenous mFOLFOX7 combined with Camrelizumab and apatinib
    Combination of systemic chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin (mFOLFOX7) , targeted drugs (Apatinib 250mg), and anti-PD-1 immunotherapy (Camrelizumab 200mg)

Primary Outcome Measure

ORR [ Time Frame: 1 year ]

Central Contacts