Hepatocellular Carcinoma Non-resectableNCT05638438
Efficacy and Safety of Transarterial Therapies+Donafenib + Anti-PD-1 Antibody for uHCC: A Retrospective Real-world Study
An observational study of Hepatocellular Carcinoma Non-resectable, run by Zhujiang Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- transarterial therapies
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Unresectable Hepatocellular Carcinoma
Who may be able to join
- clinically or histopathologically diagnosed HCC;
- not suitable for curative surgery, or local ablation;
- age 18~75 years；
- 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)
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet.
About this 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
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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- transarterial therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transarterial therapiesProcedure or surgery
Also called donafenib, Anti-PD-1 Antibody
transarterial therapies combine with donafenib and Anti-PD-1 Antibody
What is being measured
The primary outcome is the main question the study is designed to answer.
the objective response rate (ORR)
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
Measured: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
Secondary outcomes (6)
disease control rate (DCR)
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
Measured: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)
The progression-free survival rate (PFSR)
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
Measured: 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)
OSR is defined as the percentage of participants who still alive at the time of 6 or 12 months.
Measured: 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)
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
Measured: 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)
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.
Measured: From the start date of the Treatment until date of death from any cause (max 24 months)
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: From the begining triplet therapy until date of death from any cause (max 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start2 Dec 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mingxin Pan, Prof., Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638438
- Sponsor's protocol ID
- 2022-KY-180-01
- Status last verified
- Nov 2022
- First submitted
- 27 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05638438
- Acronym / sponsor ID
- 2022-KY-180-01
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 2 Dec 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Unresectable Hepatocellular Carcinoma
Key inclusion criteria (5 listed)
- clinically or histopathologically diagnosed HCC;
- not suitable for curative surgery, or local ablation;
- age 18~75 years；
- 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)
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transarterial therapiesAlso: donafenib, Anti-PD-1 Antibodytransarterial therapies combine with donafenib and Anti-PD-1 Antibody | Procedure or surgery | – |
Primary outcome
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
6 secondary outcomes
disease control rate (DCR)
Time frame: 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)
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)
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 median overall survival time (mOS)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingxin Pan, Prof. principal investigator
Southern Medical University, China
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma Non-resectable, run by Zhujiang Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingxin Pan, Prof. (18928918216 ext. 18928918216, pmxwxy@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the objective response rate (ORR) (time frame: From date of begining triplet therapy until disease progression or unacceptable toxicity (max 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.