Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study

Zhujiang Hospital

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma Non-resectable

Treatments: Procedure: transarterial therapies

Study type: Observational

Funder types: Other

Identifiers

NCT05638438

2022-KY-180-01

Details and patient eligibility

About

This Retrospective Real-world study was designed to evaluate the clinical efficacy and safety of the Combination of transarterial therapies with donafenib plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma.

Full description

Data of Patients who have received Triplet therapy ( transarterial therapies+donafenib+Anti-PD-1 Antibody）will be collected，excluding incomplete data.

The primary endpoint was the objective response rate (ORR)，Secondary endpoints included 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)， as well as adverse event.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. clinically or histopathologically diagnosed HCC;
2. not suitable for curative surgery, or local ablation;
3. age 18~75 years；
4. Barcelona Clinic Liver Cancer (BCLC) Stage-B or C HCC; 5) Child-Pugh score A or B7; 6) Eastern Cooperative Group (ECOG) performance status ≤1.;

7）no serious heart, lung, or renal dysfunction； 8）at least 1 measurable lesion according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)

Exclusion criteria

1）comorbidity with other severe systemic diseases; 2）life expectancy is less than 3 months; 3) discontinuation of treatment for personal reasons or inability to tolerate; 4）incomplete data.