BCLC Stage B Hepatocellular CarcinomaNCT06632093
HAIC in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced HCC After the Failure of Systemic Therapy Recommended by BCLC
An observational study of BCLC Stage B Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, 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 intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy
- What is being tested?
- hepatic artery infusion chemotherapy and Lenvatinib + PD-1 monoclonal antibody
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2024to 30 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib 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 received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
- Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
- Received at least 2 cycles of HAIC；
- Has repeated measurable intrahepatic lesions;
- Child-Pugh class A or B.
Who cannot join
- The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
- With other malignant tumors;
- Unable to meet criteria of combination timeframe described above.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The first hospital of China medical university
Shenyang, Liaoning, 110000
Haibo Shao, +8618940279150, dmuvictor@163.com
About this study
Official title: Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
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 intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
- Conditions
- BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, PD-1, Systemic Therapy
- Being tested
- hepatic artery infusion chemotherapy, Lenvatinib + PD-1 monoclonal antibody
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
Lenvatinib + PD-1 monoclonal antibodyDrug
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
| Study group | Role | What they receive |
|---|---|---|
| HAIC plus Lenvatinib and PD-1 inhibitors | Each patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks. Receives: Procedure: hepatic artery infusion chemotherapy; Drug: Lenvatinib + PD-1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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 (8)
Progression free survival(PFS) (Overall)
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
Progression free survival(PFS) of intra-hepatic lesions
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Progression free survival(PFS) of extra-hepatic lesions
The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.
Measured: Up to approximately 2 years
Progression free survival(PFS) of portal vein tumor thrombus (PVTT)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT 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
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 Sep 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BCLC Stage B 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
- Retrospective
- Enrolment
- 84 participants (estimated)
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
- NCT06632093
- Sponsor's protocol ID
- CHANCE2417
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Hepatic Arterial Infusion Chemotherapy in Combination with PD-1 Inhibitors and Lenvatinib for Intermediate and Advanced Hepatocellular Carcinoma After the Failure of Systemic Therapy Recommended by BCLC
- ClinicalTrials.gov ID
- NCT06632093
- Acronym / sponsor ID
- CHANCE2417
- Conditions
- BCLC Stage B Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, Lenvatinib, PD-1, Systemic Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 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 intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC plus Lenvatinib and PD-1 inhibitors | – | Procedure: hepatic artery infusion chemotherapy, Drug: Lenvatinib + PD-1 monoclonal antibodyEach patient should receive at least 2 cycles of HAIC and 1cycles of PD-1 plus Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib 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 received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
- Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1 inhibitor/ Lenvatinib treatment or before treatment;
Key exclusion criteria (3 listed)
- The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
- 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 Lenvatinib and PD-1 inhibitors |
| Lenvatinib + PD-1 monoclonal antibodyPD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab | Drug | HAIC plus Lenvatinib and PD-1 inhibitors |
Primary outcome
Overall survival
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.
8 secondary outcomes
Progression free survival(PFS) (Overall)
Time frame: Up to approximately 2 years
Progression free survival(PFS) of intra-hepatic lesions
Time frame: Up to approximately 2 years
Progression free survival(PFS) of extra-hepatic lesions
Time frame: Up to approximately 2 years
Progression free survival(PFS) of portal vein tumor thrombus (PVTT)
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
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.
- 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.
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 BCLC Stage B Hepatocellular Carcinoma and BCLC Stage C Hepatocellular Carcinoma, 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?
Contact Jiaxi Liu (+8618940279150, dmuvictor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (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.