Liver CancerPhase 1/2NCT07587034
HAIC-TACE Plus Apatinib and Camrelizumab for Liver Cancer
A Phase 1/2 study testing HTAC, HAC and TAC in people with Liver Cancer, run by Shanghai Zhongshan Hospital.
Trial summary
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- HTAC, HAC and TAC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age 18-80 years.
- Diagnosed with hepatocellular carcinoma (HCC) in accordance with the Standardization for Diagnosis and Treatment of Primary Hepatic Carcinoma (2024 Edition) issued by the National Health Commission of the People's Republic of China.
- BCLC stage B or C, with no indication or refusal of surgical treatment, and measurable lesions meeting the mRECIST (Modified Response Evaluation Criteria in Solid Tumors) criteria on baseline imaging.
- Child-Pugh liver function grade A or well-compensated grade B (score ≤7).
- ECOG Performance Status (PS) score 0-1.
- Expected survival time ≥12 weeks.
Who cannot join
- Prior transarterial chemoembolization (TACE) or other local therapies for HCC (except bridging liver transplantation).
- Active viral hepatitis (hepatitis B or C) with pre-treatment viral load >100 IU/mL (positive for HCV RNA or HBV DNA) or without consistent antiviral therapy.
- Alcohol abuse or pregnancy.
- Concurrent other malignancies or history of other malignancies within the past 3 years.
- Renal dysfunction (creatinine [Cr] >2 mg/dL or creatinine clearance [CCr] <30 mL/min) or severe organic diseases of vital organs (heart, lung, brain, etc.).
- Inability to cooperate with interventional procedures.
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- Presence of distant metastasis.
- Main portal vein tumor thrombus accompanied by impaired portal venous blood flow and collateral circulation.
- Withdrawal Criteria
- Identification of non-compliance with the study protocol during the trial.
- Administration of radiotherapy or other interventions during the trial that prevent efficacy evaluation.
- Discontinuation of treatment due to severe adverse reactions (excluded from efficacy analysis but included in adverse reaction statistics).
- Patient or representative withdraws informed consent or requests to stop treatment.
- Loss to follow-up or death of the patient.
- Key Terminology Notes
- National Health Commission of the People's Republic of China: Official English name of the Chinese health authority, consistent with government documentation.
- Standardization for Diagnosis and Treatment of Primary Hepatic Carcinoma (2024 Edition) : Translated title of the 2024 national guideline for HCC diagnosis and treatment, aligning with the 2022 edition's official English translation published in Cancer Research on Prevention and Treatment.
- mRECIST: Abbreviation for Modified Response Evaluation Criteria in Solid Tumors, the standard for assessing treatment response in HCC, widely used in clinical trials.
- BCLC Staging: Barcelona Clinic Liver Cancer staging system, a globally recognized framework for HCC prognosis and treatment decision-making.
- Child-Pugh Score: A widely used tool to assess liver function in patients with cirrhosis, with grades A (5-6 points), B (7-9 points), and C (10-15 points).
- ECOG PS Score: Eastern Cooperative Oncology Group Performance Status, a scale from 0 (fully active) to 5 (dead) used to evaluate a patient's ability to perform daily activities.
About this study
Official title: MATCH-001: A Multicenter, Open-Label, Randomized Controlled Trial of Hepatic Arterial Infusion Chemotherapy Followed by Transarterial Chemoembolization Combined With Apatinib and Camrelizumab in Patients With Intermediate and Advanced Hepatocellular Carcinoma
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
- Conditions
- Liver Cancer
- Being tested
- HTAC, HAC, TAC
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HTACProcedure or surgery
Patients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy.
HACProcedure or surgery
Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab.
TACProcedure or surgery
Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab.
| Study group | Role | What they receive |
|---|---|---|
| HTAC Group | Experimental | Patients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy. Receives: Procedure: HTAC |
| HAC Group | Experimental | Patients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. Receives: Procedure: HAC |
| TAC Group | Experimental | Patients will be treated with a regimen combining TACE, apatinib, and camrelizumab. Receives: Procedure: TAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]
Definition: The time from enrollment to tumor progression or death from any cause.
Assessment: Evaluated and judged by the investigator based on the mRECIST criteria.
Measured: Up to 27 months.
Secondary outcomes (5)
Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria]
The proportion of patients with objective tumor response, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR) and partial response (PR).
Measured: Up to 27 months
Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria]
The proportion of patients with controlled tumor disease, as evaluated by the investigator using both mRECIST and RECICL criteria, including cases of complete response (CR), partial response (PR), and stable disease (SD) (lasting for more than 4 weeks)
Measured: Up to 27 months
Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria]
Definition: The time from the first assessment of complete response (CR) or partial response (PR) to the first assessment of progressive disease (PD) or death from any cause.
Assessment: Evaluated and judged by the investigator based on both RECICL and mRECIST criteria.
Measured: Up to 27 months
Overall Survival (OS)
The time from enrollment to death from any cause.
Measured: Up to 27 months
Progression-Free Survival (PFS) [Assessed by RECIST Criteria]
Definition: The time from enrollment to tumor progression or death from any cause.
Assessment: Evaluated and judged by the investigator based on the RECICL criteria.
Measured: Up to 27 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University, Nantong First People's Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Shandong Public Health Clinical Center, Shanghai Xuhui Hospital, The fifth Hospital Affiliated To WZMU
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587034
- Sponsor's protocol ID
- MATCH-001
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MATCH-001: A Multicenter, Open-Label, Randomized Controlled Trial of Hepatic Arterial Infusion Chemotherapy Followed by Transarterial Chemoembolization Combined With Apatinib and Camrelizumab in Patients With Intermediate and Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07587034
- Acronym / sponsor ID
- MATCH-001
- Conditions
- Liver Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Nantong University, Nantong First People's Hospital, The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China, Shandong Public Health Clinical Center, Shanghai Xuhui Hospital, The fifth Hospital Affiliated To WZMU
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 14 May 2026 (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.
To provide evidence-based medical evidence for the optimized combination strategy of local and systemic therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HTAC Group | Experimental | Procedure: HTACPatients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy. |
| HAC Group | Experimental | Procedure: HACPatients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. |
| TAC Group | Experimental | Procedure: TACPatients will be treated with a regimen combining TACE, apatinib, and camrelizumab. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 years.
- Diagnosed with hepatocellular carcinoma (HCC) in accordance with the Standardization for Diagnosis and Treatment of Primary Hepatic Carcinoma (2024 Edition) issued by the National Health Commission of the People's Republic of China.
- BCLC stage B or C, with no indication or refusal of surgical treatment, and measurable lesions meeting the mRECIST (Modified Response Evaluation Criteria in Solid Tumors) criteria on baseline imaging.
- Child-Pugh liver function grade A or well-compensated grade B (score ≤7).
- ECOG Performance Status (PS) score 0-1.
Key exclusion criteria (21 listed)
- Prior transarterial chemoembolization (TACE) or other local therapies for HCC (except bridging liver transplantation).
- Active viral hepatitis (hepatitis B or C) with pre-treatment viral load >100 IU/mL (positive for HCV RNA or HBV DNA) or without consistent antiviral therapy.
- Alcohol abuse or pregnancy.
- Concurrent other malignancies or history of other malignancies within the past 3 years.
- Renal dysfunction (creatinine [Cr] >2 mg/dL or creatinine clearance [CCr] <30 mL/min) or severe organic diseases of vital organs (heart, lung, brain, etc.).
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 |
|---|---|---|
| HTACPatients will first undergo hepatic arterial infusion chemotherapy (HAIC) treatment. Subsequently, transarterial chemoembolization (TACE) will be administered sequentially following the completion of HAIC. This regimen will be combined with apatinib (a vascular endothelial growth factor receptor 2 [VEGFR-2] inhibitor) and camrelizumab (a programmed cell death protein 1 [PD-1] inhibitor) therapy. | Procedure or surgery | HTAC Group |
| HACPatients will receive a combination therapy consisting of HAIC, apatinib, and camrelizumab. | Procedure or surgery | HAC Group |
| TACPatients will be treated with a regimen combining TACE, apatinib, and camrelizumab. | Procedure or surgery | TAC Group |
Primary outcome
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria]
Time frame: Up to 27 months.
Definition: The time from enrollment to tumor progression or death from any cause. Assessment: Evaluated and judged by the investigator based on the mRECIST criteria.
5 secondary outcomes
Objective Response Rate (ORR) [Assessed by mRECIST and RECIST Criteria]
Time frame: Up to 27 months
Disease Control Rate (DCR) [Assessed by mRECIST and RECIST Criteria]
Time frame: Up to 27 months
Duration of Response (DoR) [Assessed by RECIST and mRECIST Criteria]
Time frame: Up to 27 months
Overall Survival (OS)
Time frame: Up to 27 months
Progression-Free Survival (PFS) [Assessed by RECIST Criteria]
Time frame: Up to 27 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HTAC, HAC and TAC in people with Liver Cancer, run by Shanghai Zhongshan Hospital.
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 6 inclusion and 21 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: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Progression-Free Survival (PFS) [Assessed by mRECIST Criteria] (time frame: Up to 27 months.). 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 20 May 2026.