Hepatic Arterial Infusion ChemotherapyNCT06632106
HAIC in Combination with Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors for Advanced HCC
An observational study of Hepatic Arterial Infusion Chemotherapy and Tyrosine Kinase Inhibitor, run by First Hospital of China Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitors
- What is being tested?
- hepatic artery infusion chemotherapy, Tyrosine kinase inhibitor (TKIs) and Immune Checkpoint Inhibitors
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2024to 30 May 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 with PVTT who received HAIC in combination with TKIs and ICIs 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 portal vein tumor thrombus;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
- Received at least 2 cycles of HAIC or ICIs treatments；
- Has repeated measurable intrahepatic lesions;
- Child-Pugh class A or B.
Who cannot join
- Patients who took systemic anti-tumor treatments before the combination therapy;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
Trial locations and contacts
1 site in 1 country.
China1 site
The first hospital of China medical university
Shenyang, Liaoning, 110000
About this study
Official title: In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study
The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
- Conditions
- Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitors, Hepatocellular Carcinoma (HCC)
- Being tested
- hepatic artery infusion chemotherapy, Tyrosine kinase inhibitor (TKIs), Immune Checkpoint Inhibitors
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatic artery infusion chemotherapyProcedure or surgery
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
Tyrosine kinase inhibitor (TKIs)Drug
TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab
Immune Checkpoint InhibitorsDrug
ICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab
| Study group | Role | What they receive |
|---|---|---|
| HAIC plus TKIs and ICIs | Each patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks. Receives: Procedure: hepatic artery infusion chemotherapy; Drug: Tyrosine kinase inhibitor (TKIs); Drug: Immune Checkpoint Inhibitors | |
| TKIs plus ICIs | Each patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks. Receives: Drug: Tyrosine kinase inhibitor (TKIs); Drug: Immune Checkpoint Inhibitors |
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 (4)
Progression free survival(PFS)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST1.1) 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 of PVTT
The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.
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 posted8 Oct 2024
- Study start16 Aug 2024
- Primary completion30 Jan 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Arterial Infusion ChemotherapyStudies 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
- Retrospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Shao, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632106
- Sponsor's protocol ID
- NICER024
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Which Tumor Burden Range Does Advanced Hepatocellular Carcinoma Patients Benefit More from Hepatic Arterial Infusion Chemotherapy Plus Immune Checkpoint Inhibitors and Tyrosine Kinase Inhibitors Than Immune Checkpoint Inhibitors Plus Tyrosine Kinase Inhibitors? a Multi-center, Retrospective, Propensity Score Matching Study
- ClinicalTrials.gov ID
- NCT06632106
- Acronym / sponsor ID
- NICER024
- Conditions
- Hepatic Arterial Infusion Chemotherapy, Tyrosine Kinase Inhibitor, Immune Checkpoint Inhibitors, Hepatocellular Carcinoma (HCC)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 16 Aug 2024 (actual)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 8 Oct 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 evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with different tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAIC plus TKIs and ICIs | – | Procedure: hepatic artery infusion chemotherapy, Drug: Tyrosine kinase inhibitor (TKIs), Drug: Immune Checkpoint InhibitorsEach patient should receive at least 2 cycles of HAIC and 1cycles of TKIs plus ICIs. The interval between HAIC and TKIs plus ICIs should be within 2 weeks. |
| TKIs plus ICIs | – | Drug: Tyrosine kinase inhibitor (TKIs), Drug: Immune Checkpoint InhibitorsEach patient should receive at least 2 cycles of ICIs. The interval between TKIs and ICIs should be within 2 weeks. |
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 with PVTT who received HAIC in combination with TKIs and ICIs under real-world practice conditions.
Key inclusion criteria (8 listed)
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both TKIs and ICIs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first TKIs/ ICIs treatment or before treatment;
Key exclusion criteria (3 listed)
- Patients who took systemic anti-tumor treatments before the combination therapy;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
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 |
|---|---|---|
| hepatic artery infusion chemotherapyHepatic arterial infusion chemotherapy including FOLFOX and RALOX | Procedure or surgery | HAIC plus TKIs and ICIs |
| Tyrosine kinase inhibitor (TKIs)TKIs including Lenvatinib, Sorafenib, Apatinib, Donafenib, Bevacizumab | Drug | HAIC plus TKIs and ICIs, TKIs plus ICIs |
| Immune Checkpoint InhibitorsICIs including Camrelizumab, Sintilimab, Tislelizumab, Pembrolizumab, Atezolizumab | Drug | HAIC plus TKIs and ICIs, TKIs plus ICIs |
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.
4 secondary outcomes
Progression free survival(PFS)
Time frame: Up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
Time frame: Up to approximately 2 years
ORR of PVTT
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 8 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatic Arterial Infusion Chemotherapy and Tyrosine Kinase Inhibitor, run by First Hospital of China Medical University 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 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 8 Oct 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 8 Oct 2024.