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

NCT ID: NCT05638438

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-02

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma Non-resectable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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transarterial therapies

transarterial therapies combine with donafenib and Anti-PD-1 Antibody

Intervention Type PROCEDURE

Other Intervention Names

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donafenib Anti-PD-1 Antibody

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mingxin Pan, Prof.

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Central Contacts

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Mingxin Pan, Prof.

Role: CONTACT

18928918216 ext. 18928918216

Other Identifiers

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2022-KY-180-01

Identifier Type: -

Identifier Source: org_study_id

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