TACE Combined With Camrelizumab and Apatinib in the Treatment of Advanced Liver Cancer

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT05550025
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • camrelizumab& apatinib — DRUG
    TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab Camrelizumab 200mg every 3 weeks. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally after meals, once a day, for continuous medication. The cumulative maximum drug use period is up to 1 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 TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab for Hepatocellular Carcinoma. The primary outcome measure is to evaluate the objective response rate (ORR) of the therapy for Hepatocellular Carcinoma. 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 the therapy for Hepatocellular Carcinoma. Moreover, this study aims to assess the safety and tolerability of the Therapy for Hepatocellular Carcinoma.

Key Dates

Start date
Dec 17, 2021
Status verified
Sep 2022
Primary completion
Nov 11, 2023
Completion
Feb 11, 2024

Study Design

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

Arms

  • Experimental: TACE combined with Apatinib and Camrelizumab
    TACE（transcatheter arterial chemoembolization） combined with Apatinib and Camrelizumab

Primary Outcome Measure

Objective response rate (ORR) by RECIST 1.1 and mRECIST [ Time Frame: From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or sponsor termination (up to approximately 3 years) ]

Central Contacts

Related Studies