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

November 27, 2022 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingxin Pan, Prof.
  • Phone Number: 18928918216 18928918216
  • Email: pmxwxy@sohu.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Unresectable Hepatocellular Carcinoma

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the objective response rate (ORR)
Time Frame: 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
From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease control rate (DCR)
Time Frame: 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
From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
The progression-free survival rate (PFSR)
Time Frame: 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
From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first (max 24 months)
The overall survival rate (OSR)
Time Frame: 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.
From date of begining triplet therapy to the date of first documentation of death from any cause, whichever occurs first (max 24 months)
The progression-free survival time (mPFS)
Time Frame: 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
From date of begining triplet therapy to the date of first documentation of disease progression or death, whichever occurs first(max 24 months)
The median overall survival time (mOS)
Time Frame: 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.
From the start date of the Treatment until date of death from any cause (max 24 months)
Adverse events
Time Frame: 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
From the begining triplet therapy until date of death from any cause (max 24 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Mingxin Pan, Prof., Southern Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 2, 2022

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

November 27, 2022

First Posted (Estimate)

December 6, 2022

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

November 27, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-KY-180-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma Non-resectable

Clinical Trials on transarterial therapies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe