Hepatocellular CarcinomaNCT06423144
PD-1/PD-L1 Inhibitors and Anti-angiogenic Therapy Combined With/Without TACE/HAIC in Patients With BCLC B/C Hepatocellular Carcinoma Beyond Up-to-7
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan Hospital.
Trial summary
This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TACE/HAIC and PD-1/PD-L1 inhibits and anti-angiogenic agents
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Oct 2024
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven
Who may be able to join
- Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
- Patients with Barcelona (BCLC) stage B and C beyond up to seven;
- Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
- Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);
- The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
- TACE was performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
- TACE treatment followed by at least 1 cycle of combination therapy, including: cTACE and DEB-TACE;
- There is at least 1 measurable lesion in the liver according to RECIST v1.1 criteria
Who cannot join
- Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;
- Patients who do not meet the above definition of combination therapy;
- Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven
This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TACE/HAIC, PD-1/PD-L1 inhibits and anti-angiogenic agents
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACE/HAICProcedure or surgery
TACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment;
PD-1/PD-L1 inhibits and anti-angiogenic agentsDrug
Agents were administrated based on the instructions recommended
| Study group | Role | What they receive |
|---|---|---|
| Group LS | Logical therapy combined with systemic therapy Receives: Procedure: TACE/HAIC; Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents | |
| Group S | Systemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents） Receives: Drug: PD-1/PD-L1 inhibits and anti-angiogenic agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1)
Measured: Up to 48 months
ORR
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1
Measured: Up to 48 months
Secondary outcomes (2)
OS
OS was defined as the interval from the date of the initial administration of any drug/procedure to death from any cause.
Measured: Up to 48 months
Safety
Safety was defined the incidence and severity of adverse events (AEs) and serious adverse events (SAEs). The severity of AEs were evaluated based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE) v5.0.
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study startMay 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (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.
- More trials run by Shanghai Zhongshan 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lan Zhang, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423144
- Sponsor's protocol ID
- ZL-2024-06
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Comparing Interventional Therapy (TACE/HAIC) Combined With PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Versus PD-1/PD-L1 Inhibitors and Anti-angiogenic Agents Alone in the First-line Treatment of Intermediate and Advanced Hepatocellular Carcinoma Beyond up to Seven
- ClinicalTrials.gov ID
- NCT06423144
- Acronym / sponsor ID
- ZL-2024-06
- Conditions
- Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 21 May 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.
This is a retrospective study that retrospectively included patients with intermediate and advanced HCC beyond up to seven who received first-line treatment with PD-1/PD-L1 inhibitors and anti-angiogenic agents combined with/without TACE/HAIC from January 01, 2019 to December 31, 2023 in the Department of Hepatic Oncology and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group LS | – | Procedure: TACE/HAIC, Drug: PD-1/PD-L1 inhibits and anti-angiogenic agentsLogical therapy combined with systemic therapy |
| Group S | – | Drug: PD-1/PD-L1 inhibits and anti-angiogenic agentsSystemic therapy alone（PD-1/PD-L1 inhibits and anti-angiogenic agents） |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate and advanced hepatocellular carcinoma beyond up to seven
Key inclusion criteria (8 listed)
- Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or clinically.
- Patients with Barcelona (BCLC) stage B and C beyond up to seven;
- Have not received any prior systemic therapy for HCC (including: chemotherapy, molecular targeted therapy, immunotherapy);
- Receiving only post-marketing PD-1/PD-L1 inhibitors in combination with anti-angiogenic agents (including, but not limited to, drugs containing hepatocellular carcinoma indications);
- The interval between the first use of PD-1/PD-L 1 inhibitors and the use of anti-angiogenic drugs is ≤ 1 week
Key exclusion criteria (3 listed)
- Cholangiocellular carcinoma, mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or hepatic fibrous laminar carcinoma that has been pathologically/histologically confirmed;
- Patients who do not meet the above definition of combination therapy;
- Patients had malignant tumors other than HCC within 5 years prior to enrollment (except cured limited tumors, including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ)
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 |
|---|---|---|
| TACE/HAICTACE/HAIC were performed within 1 month prior/after the first PD-1/PD-L 1 inhibitor/antiangiogenic drug treatment; | Procedure or surgery | Group LS |
| PD-1/PD-L1 inhibits and anti-angiogenic agentsAgents were administrated based on the instructions recommended | Drug | Group LS, Group S |
Primary outcome
PFS
Time frame: Up to 48 months
The time from the beginning of treatment to the time of tumor progression or death from any cause (according to mRECIST and RECIST v1.1)
ORR
Time frame: Up to 48 months
The percentage of patients who have best overall response of complete response (CR) or partial response (PR) according to mRECIST and RECIST v1.1
2 secondary outcomes
OS
Time frame: Up to 48 months
Safety
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Shanghai Zhongshan 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 8 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 21 May 2024. 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 Lan Zhang, MD, Ph.D (13918876432, zhang.lan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 48 months). The study lists 2 primary outcomes in all. 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 21 May 2024.