HCC - Hepatocellular CarcinomaNCT06631326
HAIC in Combination With PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)
An observational study of HCC - Hepatocellular Carcinoma and Hepatic Arterial Infusion Chemotherapy, 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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, BCLC Stage C Hepatocellular Carcinoma
- 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
- 244 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 22 Oct 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.
Who may be able to join
- Age 18 to 80 years old;
- Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
- At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
- HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
- Presence of PVTT;
- Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
- Child-Pugh class A or B7;
- Tumor burden meets up to 7 out criteria.
Who cannot join
- Patients who took anti-tumor treatments before the combination therapy;
- With other malignant tumors;
- incomplete data.
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: Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation 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 high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).
- Conditions
- HCC - Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, BCLC Stage C Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitors
- Being tested
- hepatic artery infusion chemotherapy, Lenvatinib + PD-1 monoclonal antibody
- 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
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, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months. Receives: Procedure: hepatic artery infusion chemotherapy; Drug: Lenvatinib + PD-1 monoclonal antibody | |
| Lenvatinib plus PD-1 inhibitors | Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib. Receives: 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 (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 (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 start1 Jan 2021
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCC - 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
- 244 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
- Investigators
- Haibo Shao, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631326
- Sponsor's protocol ID
- CHANCE2416
- Status last verified
- Jan 2026
- First submitted
- 5 Oct 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu J, Zhang S, Shao H. Hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors as first-line treatment for hepatocellular carcinoma with high tumour burden and portal vein tumour thrombus (CHANCE 2416): study protocol of a multicentre, retrospective, target trial emulation design. BMJ Open. 2025 Sep 9;15(9):e099510. doi: 10.1136/bmjopen-2025-099510.
PubMed 40930561
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors as First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: a Target Trial Emulation Study
- ClinicalTrials.gov ID
- NCT06631326
- Acronym / sponsor ID
- CHANCE2416
- Conditions
- HCC - Hepatocellular Carcinoma, Hepatic Arterial Infusion Chemotherapy, BCLC Stage C Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- 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 high 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 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, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months. |
| Lenvatinib plus PD-1 inhibitors | – | Drug: Lenvatinib + PD-1 monoclonal antibodyEach patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with high tumor burden advanced HCC with PVTT who received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.
Key inclusion criteria (8 listed)
- Age 18 to 80 years old;
- Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
- At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
- HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
- Presence of PVTT;
Key exclusion criteria (3 listed)
- Patients who took anti-tumor treatments before the combination therapy;
- With other malignant tumors;
- incomplete data.
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, Lenvatinib plus PD-1 inhibitors |
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.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Derived from this study: PubMed 40930561Liu J, Zhang S, Shao H. Hepatic arterial infusion chemotherapy plus lenvatinib and PD-1 inhibitors versus lenvatinib plus PD-1 inhibitors as first-line treatment for hepatocellular carcinoma with high tumour burden and portal vein tumour thrombus (CHANCE 2416): study protocol of a multicentre, retrospective, target trial emulation design. BMJ Open. 2025 Sep 9;15(9):e099510. doi: 10.1136/bmjopen-2025-099510.
- 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.
Haibo Shao principal investigator
First Hospital of China Medical University
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 HCC - Hepatocellular Carcinoma and Hepatic Arterial Infusion Chemotherapy, 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: finished, as of the sponsor's last update on 27 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
On the ClinicalTrials.gov record for NCT06631326, which also lists 1 linked publication.
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 27 Jan 2026; AzTrials last refreshed its copy on 26 Oct 2026.