Liver CancerPhase 4NCT07790419
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion
A Phase 4 study testing HAIC, Donafenib + lenvatinib+apatinib and Sintilimab+camrelizumab+tislelizumab in people with Liver Cancer, run by Zhai Wenlong at 1 site in China.
Trial summary
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion 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?
- HAIC, Donafenib + lenvatinib+apatinib and Sintilimab+camrelizumab+tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to 31 Dec 2028
- Phase
- Phase 4
- 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, male or female;
- Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;
- Microvascular invasion (MVI) grade ≥ 1
- No other history of tumors and no preoperative anticancer treatment.
- ECOG: 0-1;
- Baseline blood count tests and blood biochemistry must meet the following criteria:
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- Hemoglobin ≥80 g/L;
- Absolute neutrophil count ≥1.5×109/L;
- Platelet count ≥50×109/L;
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5 times the upper limit of normal (ULN);
- Total bilirubin ≤3 times ULN;
- Serum creatinine ≤1.5 times ULN;
- Albumin ≥28 g/L; prothrombin time (PT) ≤19.5 s;
- International normalized ratio (INR) ≤2.3
- Women of childbearing potential must agree to use contraception during the study and for 6 months after the study ends (e.g., intrauterine device, oral contraceptives, or condoms); serum or urine pregnancy test must be negative within 7 days before enrollment, and they must not be breastfeeding; men must agree to use contraception during the study and for 6 months after the study ends;
- Subjects voluntarily participate in this study, sign the informed consent form, are compliant, and cooperate with follow-up.
Who cannot join
- 1. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);
- 2. Pregnancy or lactation;
- 3. Over 80 years old;
- 4. Prior systemic chemotherapy or radiotherapy;
- 5. Concomitant malignant pleural effusion or ascites;
- 6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
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- 7. Concomitant infection requiring anti-infective treatment;
- 8. Concomitant peripheral nervous system disease or a history of significant psychiatric disease and central nervous system disease;
- 9. Diagnosis of other types of malignant tumors within 5 years, excluding non-melanoma skin cancer and carcinoma in situ of the cervix;
- 10. Uncorrectable coagulation disorders;
- 11. Significant ECG abnormalities or obvious clinical symptoms of heart disease, such as congestive heart failure (CHF), clinically significant coronary heart disease, difficult-to-control arrhythmias, and hypertension;
- 12. History of myocardial infarction within 12 months, or cardiac function class III or IV;
- 13. Severe liver disease (e.g., cirrhosis), kidney disease, respiratory disease, uncontrolled diabetes, or other systemic diseases;
- 14. Individuals deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Wenlong Zhai, MD, +86-371-66862231, ven0371@126.com
About this study
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion
- Conditions
- Liver Cancer
- Being tested
- HAIC, Donafenib + lenvatinib+apatinib, Sintilimab+camrelizumab+tislelizumab
- Keywords
- HAIC
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAICRadiation
Oxaliplatin and 5-Fluorouracil（5-FU）administeredvia hepatic artery infusion
Donafenib + lenvatinib+apatinibDrug
Oraltargeted therapy administered daily
Sintilimab+camrelizumab+tislelizumabDrug
PD--1 inhibitor administered viaintravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| HAIC+Targeted Therapy +PD-1 Inhibitor | Experimental | Hepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows:
Oxaliplatin 65 mg/m², IA (intra-arterial), Day 1, 0-5 hours:
5-FU 1200 mg/m², IA, maintained for 23 hours.
After catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge.
The above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles.
Targeted drugs:
Including lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight <60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects.
PD-1 inhibitors
: sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt.
This study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the Receives: Radiation: HAIC; Drug: Donafenib + lenvatinib+apatinib; Drug: Sintilimab+camrelizumab+tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS)
Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first.
Measured: From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.
Secondary outcomes (1)
Overall survival (OS)
Overall survival (OS) is defined as the time from randomization to death from any cause. For subjects lost to follow-up before death, the time of last follow-up is generally used as the death time.
Measured: From the date of randomization until death from any cause, assessed up to 28 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhai Wenlong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhai Wenlong, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790419
- Sponsor's protocol ID
- 2025-KY-2003-002
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined With Targeted Therapy and a PD-1 Inhibitor in Patients With Postoperative Hepatocellular Carcinoma and Microvascular Invasion
- ClinicalTrials.gov ID
- NCT07790419
- Acronym / sponsor ID
- 2025-KY-2003-002
- Conditions
- Liver Cancer
- Keywords
- HAIC
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhai WenlongUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 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.
A Prospective, Single-Arm, Open-Label Clinical Study of the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Combined with Targeted Therapy and a PD-1 Inhibitor in Patients with Postoperative Hepatocellular Carcinoma and Microvascular Invasion
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC+Targeted Therapy +PD-1 Inhibitor | Experimental | Radiation: HAIC, Drug: Donafenib + lenvatinib+apatinib, Drug: Sintilimab+camrelizumab+tislelizumabHepatic arterial infusion chemotherapy (HAIC): to be performed within 4-8 weeks after liver cancer surgery, as follows: Oxaliplatin 65 mg/m², IA (intra-arterial), Day 1, 0-5 hours: 5-FU 1200 mg/m², IA, maintained for 23 hours. After catheter removal, a pressure dressing for hemostasis for 6-12 hours is sufficient before discharge. The above HAIC treatment will be repeated every 3-4 weeks for a total of 2 cycles. Targeted drugs: Including lenvatinib: oral administration according to body weight; body weight ≥60 kg, 8-12 mg QD; body weight <60 kg, 4-8 mg QD; donafenib: 80 mg BID; apatinib: 250 mg QD. The above targeted drugs will be appropriately adjusted according to the patient's tolerance to toxic side effects. PD-1 inhibitors : sintilimab 200 mg Q3W, ivgtt; camrelizumab 200 mg Q3W, ivgtt; tislelizumab 200 mg Q3W, ivgtt. This study will follow participants for disease recurrence and disease-free survival for at least 2 years. After all participants complete treatment or the |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18-80 years, male or female;
- Pathologically confirmed hepatocellular carcinoma, with complete resection of all tumor nodules and negative surgical margins;
- Microvascular invasion (MVI) grade ≥ 1
- No other history of tumors and no preoperative anticancer treatment.
- ECOG: 0-1;
Key exclusion criteria (14 listed)
- 1. Patients with any active autoimmune disease or a history of autoimmune disease (including, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; patients whose childhood asthma has completely resolved and who require no intervention as adults may be included; asthma requiring bronchodilator intervention for medical management cannot be included);
- 2. Pregnancy or lactation;
- 3. Over 80 years old;
- 4. Prior systemic chemotherapy or radiotherapy;
- 5. Concomitant malignant pleural effusion or ascites;
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 |
|---|---|---|
| HAICOxaliplatin and 5-Fluorouracil（5-FU）administeredvia hepatic artery infusion | Radiation | HAIC+Targeted Therapy +PD-1 Inhibitor |
| Donafenib + lenvatinib+apatinibOraltargeted therapy administered daily | Drug | HAIC+Targeted Therapy +PD-1 Inhibitor |
| Sintilimab+camrelizumab+tislelizumabPD--1 inhibitor administered viaintravenous infusion | Drug | HAIC+Targeted Therapy +PD-1 Inhibitor |
Primary outcome
Disease-free survival (DFS)
Time frame: From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 months.
Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented tumor recurrence, metastasis, or death from any cause, whichever occurs first.
1 secondary outcome
Overall survival (OS)
Time frame: From the date of randomization until death from any cause, assessed up to 28 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 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HAIC, Donafenib + lenvatinib+apatinib and Sintilimab+camrelizumab+tislelizumab in people with Liver Cancer, run by Zhai Wenlong 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 16 inclusion and 14 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 27 Aug 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Wenlong Zhai, MD (+86-371-66862231, ven0371@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) (time frame: From the date of randomization until the date of first documented recurrence or death from any cause, whichever came first, assessed up to 28 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 27 Aug 2026.