Clinical trial NCT05638438: Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Non-resectable
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Unresectable Hepatocellular Carcinoma

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.

Eligibility 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.

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Primary outcomes:
measure: the objective response rate (ORR)
timeFrame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
Secondary outcomes:
measure: disease control rate (DCR)
timeFrame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
measure: The progression-free survival rate (PFSR)
timeFrame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)
measure: The overall survival rate (OSR)
timeFrame: From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)
measure: The progression-free survival time (mPFS)
timeFrame: From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)
measure: The median overall survival time (mOS)
timeFrame: From the start date of the Treatment until date of death from any cause (max 24 months)
measure: Adverse events
timeFrame: From the begining triplet therapy until date of death from any cause (max 24 months)
Other outcomes:
Locations:
Study officials:
affiliation: Southern Medical University, China
name: Mingxin Pan, Prof.
role: PRINCIPAL_INVESTIGATOR
References: