Hepatocellular CarcinomaNCT06607120
Prognosis Stratification for Advanced HCC Receiving TACE with PD-1/PD-L1 Inhibitors and Molecular Target Therapies
An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
Trial summary
The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 950 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions
Who may be able to join
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after TACE treatment;
- Has repeated measurable intrahepatic lesions;
Who cannot join
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS>2 or Severe hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital
Nanjing, Jiangsu
Gao-Jun Teng, M.D, +86-02583272121, gjteng@vip.sina.com
About this study
Official title: Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies
The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.
Read the detailed description
In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection for clinical practice and trials.
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint inhibitors, molecular target therapies, advanced stage, prognosis model
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival(OS)
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Measured: up to approximately 2 years
Secondary outcomes (9)
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Measured: up to approximately 2 years
ORR per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Measured: up to approximately 2 years
Duration of Response (DOR) per RESCIST 1.1
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to RESCIST 1.1) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
DOR per mRECIST
DOR is determined by disease assessment and is defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression (according to mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD)per RESCIST 1.1.
Measured: up to approximately 2 years
DCR per mRECIST
DCR is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD) per mRECIST.
Measured: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Measured: up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jun 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao- Teng, M.D, Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607120
- Sponsor's protocol ID
- CHANCE2420
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Model of Prognosis Stratification for Patients with Advanced HCC Receiving TACE Combined with PD-1/PD-L1 Inhibitors Plus Molecular Target Therapies
- ClinicalTrials.gov ID
- NCT06607120
- Acronym / sponsor ID
- CHANCE2420
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, transarterial chemoembolization, immune checkpoint inhibitors, molecular target therapies, advanced stage, prognosis model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Sep 2024 (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.
The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage hepatocellular carcinoma (HCC) receiving transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies.
Detailed description
In patients with advanced-stage hepatocellular carcinoma (HCC), previous studies showed that transarterial chemoembolization (TACE) in combination with immune checkpoint inhibitors (ICIs) and molecular target therapies exhibited better efficacy (PFS and OS) as compared to the ICIs and molecular target therapies. However, there is a lack of effective tools to select those who will benefit the most from that combination therapy. The purpose of this study is to establish a personalized model of prognosis stratification for patients with advanced-stage HCC who receive TACE and immune checkpoint ICIs plus molecular target therapies (including, VEGF-TKI/ bevacizumab). This real-world study may provide further information on treatment selection for clinical practice and trials.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced HCC who received TACE in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions
Key inclusion criteria (7 listed)
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of extrahepatic spread and/or macrovascular invasion;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- TACE was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months);
Key exclusion criteria (3 listed)
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS>2 or Severe hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival(OS)
Time frame: up to approximately 2 years
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
9 secondary outcomes
Progression free survival(PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time frame: up to approximately 2 years
PFS per Modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time frame: up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
Time frame: up to approximately 2 years
ORR per mRECIST
Time frame: up to approximately 2 years
Duration of Response (DOR) per RESCIST 1.1
Time frame: up to approximately 2 years
DOR per mRECIST
Time frame: up to approximately 2 years
Disease Control Rate (DCR) per RESCIST 1.1
Time frame: up to approximately 2 years
DCR per mRECIST
Time frame: up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
Time frame: up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
Gao- Teng, M.D principal investigator
Zhongda hospital, Southeast university, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Zhongda Hospital at 1 site in China.
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 7 inclusion and 3 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 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gao-Jun Teng, M.D (+86-02583272121, gjteng@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival(OS) (time frame: up to approximately 2 years). 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 23 Sep 2024.