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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05638438
Other study ID # 2022-KY-180-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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. -

Study Design


Related Conditions & MeSH terms


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)
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