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

Hepatocellular Carcinoma Non-resectable Clinical Trial

Official title:

Efficacy and Safety of the Combination of Transarterial Therapies With Donafenib Plus Anti-PD-1 Antibody for Unresectable Hepatocellular Carcinoma: A Retrospective Real-world Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05638438
• Other study ID #: 2022-KY-180-01
• Status: Not yet recruiting
• Start date: December 2, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: Zhujiang Hospital
• Contact: Mingxin Pan, Prof.
• Phone: 18928918216
• Email: pmxwxy[@]sohu.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma Non-resectable

Intervention

Procedure:
• transarterial therapies
transarterial therapies combine with donafenib and Anti-PD-1 Antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the objective response rate (ORR)	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	From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
Secondary	disease control rate (DCR)	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	From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
Secondary	The progression-free survival rate (PFSR)	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	From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)
Secondary	The overall survival rate (OSR)	OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months.	From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)
Secondary	The progression-free survival time (mPFS)	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	From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)
Secondary	The median overall survival time (mOS)	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.	From the start date of the Treatment until date of death from any cause (max 24 months)
Secondary	Adverse events	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	From the begining triplet therapy until date of death from any cause (max 24 months)