Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study
Study Details
Study Description
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.
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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 Design
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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clinically or histopathologically diagnosed HCC;
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not suitable for curative surgery, or local ablation;
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age 18~75 years；
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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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Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Zhujiang Hospital
Investigators
- Principal Investigator: Mingxin Pan, Prof., Southern Medical University, China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-KY-180-01