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

Not yet recruiting

• Conditions: Hepatocellular Carcinoma Non-resectable

• Registration Number: NCT05638438
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-27
• Study First Submitted QC: 2022-11-27
• Last Update Submitted: 2022-11-27
• Study Start: 2022-12-02
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the objective response rate (ORR)	From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)	ORR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST

Secondary Outcome Measures

Name	Time	Method
disease control rate (DCR)	From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)	DCR is defined as the percentage of participants who have best overall response (BOR) of complete response (CR) or partial response (PR) or stable disease (SD) at the time of data cutoff as assessed by RECIST 1.1 and mRECIST
The progression-free survival rate (PFSR)	From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)	PFSR is defined as the percentage of participants who have not accured disease progression or death at the time of 6 or 12 months as assessed by RECIST 1.1 and mRECIST
The overall survival rate (OSR)	From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)	OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months.
The progression-free survival time (mPFS)	From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)	The progression-free survival time (mPFS) defined as the time from begining triplet therapy to the date of first documentation of disease progression as assessed by RECIST 1.1 and mRECIST
The median overall survival time (mOS)	From the start date of the Treatment until date of death from any cause (max 24 months)	OS is measured from the start date of the Treatment (date of begining triplet therapy) until date of death from any cause. Participants who are lost to follow-up and the participants who are alive at the date of data cutoff will be censored at the date the participant was last known alive or the cut-off date, whichever comes earlier.
Adverse events	From the begining triplet therapy until date of death from any cause (max 24 months)	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0