Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hepatocellular Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

This is a prospective, single arm, phase 2 study to evaluate the efficacy and safety of cryoablation combined with Camrelizumab and Apatinib (C-couple Therapy) in patients with advanced HCC. Subjects who meet the admission criteria will be treated with Camrelizumab and Apatinib after cryoablation un...

This is a prospective, single arm, phase 2 study to evaluate the efficacy and safety of cryoablation combined with Camrelizumab and Apatinib (C-couple Therapy) in patients with advanced HCC. Subjects who meet the admission criteria will be treated with Camrelizumab and Apatinib after cryoablation until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued. The primary outcome measure is to evaluate the objective response rate (ORR) of C-couple Therapy for advanced HCC (BCLC C-stage). The secondary outcome measures include the duration of response (DOR), disease control rate (DCR), progression-free survival rate (PFSR) in 6- and 12-months, overall survival rate (OSR) in 6- and 12-months, the median progression-free survival time (mPFS) and median overall survival time (mOS) of C-couple Therapy for advanced HCC. This study also aims to assess the safety and adverse reactions of C-couple Therapy for advanced HCC.

Tracking Information

NCT #
NCT04724226
Collaborators
Not Provided
Investigators
Not Provided