Hepatocellular Carcinoma (HCC)NCT06881433
Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without HAIC for Unresectable HCC With Portal Vein Tumor Thrombosis
An observational study of Hepatocellular Carcinoma (HCC), run by Zhongda Hospital at 1 site in China.
Trial summary
Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors (VEGF/TKI-ICI) plus Immune checkpoint inhibitors (ICIs) are recommended for patients with unresectable hepatocellular carcinoma (HCC) with PVTT in China. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- How many people
- 1,649 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 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 80 years
- All sexes
- Adult, Older adult
Study population: Patients with unresectable HCC and PVTT who received HAIC in combination with PD-1/PD-L1 inhibitors and molecular target therapies 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 (HCC with PVTT);
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 2 months);
- Received at least 1 cycle of PD-1/PD-L1 inhibitor/anti-angiogenic drug combination therapy after HAIC treatment;
- Has repeated measurable intrahepatic lesions;
Who cannot join
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS>2 or Severe hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
About this study
Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors (VEGF/TKI-ICI) plus Immune checkpoint inhibitors (ICIs) are recommended for patients with unresectable hepatocellular carcinoma (HCC) with PVTT in China. However, these treatments have limited survival benefit in patients with advanced HCC with PVTT. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with VEGF/TKI-ICI and ICIs could improve the efficacy.
Read the detailed description
The multiple real-world studies have shown that Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors plus immune checkpoint inhibitors (ICIs) (VEGF/TKI-ICI) does not result in a high response rate or extended survival for patients with extrahepatic metastases, with an objective response rate (ORR) of less than 20%. Therefore, there is an urgent need to explore effective therapeutic strategies that can enhance the combined antitumor efficacy of (VEGF/TKI-ICI) and improve the prognosis of patients with advanced hepatocellular carcinoma (HCC) with PVTT. In addition to VEGF/TKI-ICI, more aggressive treatments, such as hepatic arterial infusion chemotherapy (HAIC), have been adopted in the Asia-Pacific region. HAIC significantly increases drug concentration in HCC tissues while decreasing drug distribution in the peripheral blood, thereby improving intrahepatic tumor control and reducing systemic adverse events (AEs). Recent significant advancements have been reported in both local-regional and systemic therapies. Furthermore, the combination of HAIC with VEGF/TKI-ICI (HAIC-VEGF/TKI-ICI) may provide potential synergistic anticancer activity for HCC based on the following rationale: HAIC can effectively kill tumors while promoting the release of tumor antigens, thus transforming "cold tumors" into "hot tumors." At the same time, VEGF/TKI can reverse the tumor neovascularization induced by interventional therapies and enhance tumor vasculature normalization. However, it remains unclear whether patients with advanced HCC can benefit from HAIC-VEGF/TKI-ICI through intrahepatic lesion control, thereby impeding tumor progression. Accordingly, this national multiple-centers retrospective study aims to compare the clinical benefits and tolerability of HAIC-VEGF/TKI-ICI versus VEGF/TKI-ICI alone.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, immune checkpoint inhibitors, molecular target therapies, hepatic infusion chemotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
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
Progression free survival(PFS) per RECIST 1.1 or mRECIST
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1 or mRECIST) or death due to any cause, whichever occurs first.
Measured: up to approximately 2 years
Secondary outcomes (3)
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
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 posted18 Mar 2025
- Study start1 Jun 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
- Investigators
- Gao-jun Teng, M.D, Principal investigator, Zhongda hospital, Southeast university, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881433
- Sponsor's protocol ID
- CHANCE2504
- Status last verified
- May 2026
- First submitted
- 12 Mar 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Checkpoint Inhibitors and Anti-vascular Endothelial Growth Factor Antibody/Tyrosine Kinase Inhibitors With or Without HAIC for Unresectable HCC With Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT06881433
- Acronym / sponsor ID
- CHANCE2504
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- hepatocellular carcinoma, immune checkpoint inhibitors, molecular target therapies, hepatic infusion chemotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Mar 2025 (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.
Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors (VEGF/TKI-ICI) plus Immune checkpoint inhibitors (ICIs) are recommended for patients with unresectable hepatocellular carcinoma (HCC) with PVTT in China. However, these treatments have limited survival benefit in patients with advanced HCC with PVTT. We aimed to investigate whether hepatic arterial infusion chemotherapy (HAIC) in combination with VEGF/TKI-ICI and ICIs could improve the efficacy.
Detailed description
The multiple real-world studies have shown that Anti-vascular endothelial growth factor antibody/tyrosine kinase inhibitors plus immune checkpoint inhibitors (ICIs) (VEGF/TKI-ICI) does not result in a high response rate or extended survival for patients with extrahepatic metastases, with an objective response rate (ORR) of less than 20%. Therefore, there is an urgent need to explore effective therapeutic strategies that can enhance the combined antitumor efficacy of (VEGF/TKI-ICI) and improve the prognosis of patients with advanced hepatocellular carcinoma (HCC) with PVTT. In addition to VEGF/TKI-ICI, more aggressive treatments, such as hepatic arterial infusion chemotherapy (HAIC), have been adopted in the Asia-Pacific region. HAIC significantly increases drug concentration in HCC tissues while decreasing drug distribution in the peripheral blood, thereby improving intrahepatic tumor control and reducing systemic adverse events (AEs). Recent significant advancements have been reported in both local-regional and systemic therapies. Furthermore, the combination of HAIC with VEGF/TKI-ICI (HAIC-VEGF/TKI-ICI) may provide potential synergistic anticancer activity for HCC based on the following rationale: HAIC can effectively kill tumors while promoting the release of tumor antigens, thus transforming "cold tumors" into "hot tumors." At the same time, VEGF/TKI can reverse the tumor neovascularization induced by interventional therapies and enhance tumor vasculature normalization. However, it remains unclear whether patients with advanced HCC can benefit from HAIC-VEGF/TKI-ICI through intrahepatic lesion control, thereby impeding tumor progression. Accordingly, this national multiple-centers retrospective study aims to compare the clinical benefits and tolerability of HAIC-VEGF/TKI-ICI versus VEGF/TKI-ICI alone.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with unresectable HCC and PVTT who received HAIC in combination with PD-1/PD-L1 inhibitors and molecular target therapies under real-world practice conditions
Key inclusion criteria (7 listed)
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
- Barcelona Clinic Liver Cancer (BCLC) stage C (HCC with PVTT);
- Has not received any previous systemic therapy for HCC (including chemotherapy, molecularly targeted therapy, immunotherapy);
- Both PD-1/PD-L1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to HCC approval;
- HAIC was performed after the first PD-1/PD-L1 inhibitor/anti-angiogenic drug treatment or before treatment (within 2 months);
Key exclusion criteria (3 listed)
- Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible;
- Unable to meet criteria of combination timeframe described above;
- Child-Pugh C or PS>2 or Severe hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Progression free survival(PFS) per RECIST 1.1 or mRECIST
Time frame: up to approximately 2 years
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to RECIST 1.1 or mRECIST) or death due to any cause, whichever occurs first.
3 secondary outcomes
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
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 11 May 2026.
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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.
Gao-jun Teng, M.D principal investigator
Zhongda hospital, Southeast university, Nanjing, China
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 (HCC), run by Zhongda 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 7 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 11 May 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). 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 11 May 2026.