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Trial Title:
Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study
NCT ID:
NCT05638438
Condition:
Hepatocellular Carcinoma Non-resectable
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
transarterial therapies
Description:
transarterial therapies combine with donafenib and Anti-PD-1 Antibody
Other name:
donafenib
Other name:
Anti-PD-1 Antibody
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.
Criteria for eligibility:
Study pop:
Patients with Unresectable Hepatocellular Carcinoma
Sampling method:
Non-Probability Sample
Criteria:
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.
-
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 2, 2022
Completion date:
September 30, 2023
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05638438
