Hepatocellular CarcinomaNCT05420922
Real-world Study of Efficacy and Safety of ICIs and TKIs Therapy for HCC
An observational study of Hepatocellular Carcinoma and Programmed Cell Death 1, run by Tongji Hospital at 1 site in China.
Trial summary
China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Programmed Cell Death 1, Effects of Immunotherapy
- What is being tested?
- Lenvatinib Oral Product, PD-1 inhibitor and Local treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2022
- 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: Hepatocellular carcinoma patients using ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib), ICIs plus TKIs with local therapy (TACE, HAIC, RF ablation, microwave ablation, etc), local therapy only
Who may be able to join
- Clinical diagnosis of hepatocellular carcinoma
- Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib)
- Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc)
- Treated Treated with ICIs plus TKIs and local therapy
- Have complete medical record that can complete the OR or 1 year OS assessment and follow-up.
Who cannot join
- Patients who do not have complete medical record and follow-up information after treatment；
- The researchers have evidence that it is not suitable for this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Xiaoping Chen, chenxpchenxp@163.com
About this study
Official title: Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China
China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.
Read the detailed description
This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.
- Being tested
- Lenvatinib Oral Product, PD-1 inhibitor, Local treatment
- Keywords
- Lenvatinib, Sorafenib, Programmed Cell Death 1, Real-world study, transcatheter arterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib Oral ProductDrug
Lenvatinib or Sorafenib
PD-1 inhibitorDrug
Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1
Local treatmentProcedure or surgery
Local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc.
| Study group | Role | What they receive |
|---|---|---|
| Systemic therapy | ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) Receives: Drug: Lenvatinib Oral Product; Drug: PD-1 inhibitor | |
| Local treatment | local treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. Receives: Procedure: Local treatment | |
| Triple therapy | Systemic therapy plus Local treatment:
ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc) Receives: Drug: Lenvatinib Oral Product; Drug: PD-1 inhibitor; Procedure: Local treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective response rate (ORR)
ORR in three groups were compared
Measured: 8 weeks
The overall survival (OS)
1 year OS in three groups were compared
Measured: 12 months
The treatment-related adverse events (TRAEs)
Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 12 months
Secondary outcomes (1)
The progression-free survival (PFS)
ORR in three groups were compared
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start1 Nov 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion31 Dec 2022 (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 Tongji 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiaoping, Tongji Hospital
- Investigators
- Xiaoping Chen, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420922
- Sponsor's protocol ID
- CHL2022
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We haven't decided whether it needs to cooperate with other PI.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immune Checkpoint Inhibitors (ICIs) and Tyrosine Kinase Inhibitors (TKIs) Therapy for Hepatocellular Carcinoma (HCC)：a Multicenter, Retrospective Study on the Real-world in China
- ClinicalTrials.gov ID
- NCT05420922
- Acronym / sponsor ID
- CHL2022
- Keywords
- Lenvatinib, Sorafenib, Programmed Cell Death 1, Real-world study, transcatheter arterial chemoembolization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 15 Jun 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.
China is a high-risk area of Hepatocellular Carcinoma (HCC). Although Chinese population accounts for 18.4% of the global population, the number of new HCC patients accounting for about half of the global, which seriously threatens the lives and health of the people. The investigators establish multi-center, retrospective research methods, collecting the data of HCC treatment with system treatment (ICIs and TKIs) plus or without local treatment in the last 3 years, comprehensive assessment of their efficacy and safety, explore whether the efficacy of system treatment combination local treatment showed better effect compared with system or local monotherapy. Our study will find a new way to improve the prognosis of HCC patients.
Detailed description
This was a multi-center, retrospective study involving 2000 patients with HCC receiving ICIs (Programmed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1)) and TKIs (Lenvatinib or Sorafenib), ICIs and TKIs plus local treatment (TAC, Hepatic artery infusion chemotherapy (HAIC), radiofrequency (RF) ablation, microwave ablation, radiotherapy, etc.), and local monotherapy between Jan, 2019 and Dec, 2021 in China. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP), and 1year and 2 years overall survival (OS). Treatment-related adverse events (TRAEs) were recorded and graded. Efficacy and safety of three groups were compared. Stratified analysis was performed according to patients baseline characteristics and medication regimen for combination therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic therapy | – | Drug: Lenvatinib Oral Product, Drug: PD-1 inhibitorICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) |
| Local treatment | – | Procedure: Local treatmentlocal treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. |
| Triple therapy | – | Drug: Lenvatinib Oral Product, Drug: PD-1 inhibitor, Procedure: Local treatmentSystemic therapy plus Local treatment: ICIs (PD1 or PDL-1)+TKIs (Lenvatinib or Sorafenib) plus local treatment (TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carcinoma patients using ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib), ICIs plus TKIs with local therapy (TACE, HAIC, RF ablation, microwave ablation, etc), local therapy only
Key inclusion criteria (5 listed)
- Clinical diagnosis of hepatocellular carcinoma
- Treated with ICIs (PD-1 or PDL-1) therapy plus TKIs (Lenvatinib or sorafenib)
- Treated with local therapy (TACE, HAIC, RF ablation, microwave ablation, radiotherapy, etc)
- Treated Treated with ICIs plus TKIs and local therapy
- Have complete medical record that can complete the OR or 1 year OS assessment and follow-up.
Key exclusion criteria (2 listed)
- Patients who do not have complete medical record and follow-up information after treatment；
- The researchers have evidence that it is not suitable for this study
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 |
|---|---|---|
| Lenvatinib Oral ProductLenvatinib or Sorafenib | Drug | Systemic therapy, Triple therapy |
| PD-1 inhibitorProgrammed cell death protein-1 (PD-1) or Programmed cell death ligand 1 (PDL-1 | Drug | Systemic therapy, Triple therapy |
| Local treatmentLocal treatment include: TACE, HAIC, RF Ablation, Microwave Ablation, Radiotherapy, etc. | Procedure or surgery | Local treatment, Triple therapy |
Primary outcome
The objective response rate (ORR)
Time frame: 8 weeks
ORR in three groups were compared
The overall survival (OS)
Time frame: 12 months
1 year OS in three groups were compared
The treatment-related adverse events (TRAEs)
Time frame: 12 months
Rate of participants with treatment-related adverse events as assessed by CTCAE v5.0
1 secondary outcome
The progression-free survival (PFS)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: Undecided. We haven't decided whether it needs to cooperate with other PI.
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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.
Xiaoping Chen, Doctor principal investigator
Tongji Hospital
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 and Programmed Cell Death 1, run by Tongji 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 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 15 Jun 2022. 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 Changhai Li, Doctor (8613986231269, tjlichanghai@126.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: 8 weeks). The study lists 3 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 15 Jun 2022.