A Trial of Hepatic Arterial Infusion Combined With Apatinib and Camrelizumab for C-staged Hepatocellular Carcinoma in BCLC Classification

Sponsor
Sun Yat-sen University
Study ID
NCT04191889
Phase
PHASE2
Status
Unknown

Conditions

  • C-staged Hepatocellular Carcinoma in BCLC Classification

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Hepatic Arterial Infusion combined with Apatinib and Camrelizumab — COMBINATION_PRODUCT
    Drug: FOLFOX Protocol (Oxaliplatin, fluorouracil, and leucovorin); Camrelizumab for injection and Apatinib-Mesylate Tablets Procedure: 1. On the first day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX7, oxaliplatin 85 mg/m2 2 hours, folinic acid 400 mg/m2, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 6 times. 2. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on day 8 in the first HAIC cycle, once a day, for continuous medication. 3. The first dose of Camrelizumab was administered on day 4 of the second HAIC cycle, at a dose of 200 mg intravenously, every three weeks. 4. The cumulative maximum drug use period is up to 2 years. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear.

Study Details

This study was designed to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy combined with Apatinib and Camrelizumab (Triplet-combined Therapy) for C-staged Hepatocellular Carcinoma in BCLC classification. The primary outcome measure is to evaluate the objective response rate (ORR) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. The secondary Outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) \[ Time Frame: 6- and 12-month\], overall survival rate (OSR) \[ Time Frame: 6- and 12-month\], the median progression-free survival time (mPFS) and median overall survival time (mOS) of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification. Moreover, this study aims to assess the safety and tolerability of Triplet-combined Therapy for C-staged Hepatocellular Carcinoma in BCLC classification.

Key Dates

Start date
Apr 13, 2020
Status verified
Sep 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: TRIPLET
    Hepatic Arterial Infusion combined with Apatinib and Camrelizumab

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 [ Time Frame: From date of first dose of study drug until disease progression (up to approximately 3 years) ]

Central Contacts