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HCC - Hepatocellular CarcinomaNCT07618546

A Multicenter, Randomized, Open-label, Controlled Study of HAIC Combined With Camrelizumab and Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma With High-risk Recurrence Factors

A study testing Camrelizumab (anti-PD-1 inhibitor), Apatinib Mesylate Tablets and FOLFOX-HAIC in people with HCC - Hepatocellular Carcinoma, run by Henan Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
HCC - Hepatocellular Carcinoma
What is being tested?
Camrelizumab (anti-PD-1 inhibitor), Apatinib Mesylate Tablets and FOLFOX-HAIC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
No sites listed yet
Study dates
25 May 2026to 31 Mar 2028
Phase
Interventional
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

  • 1: 1. Age 18-80, both male and female are acceptable;
  • 2: 2. Hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or imaging, with CNLC staging of Ia-IIIa, excluding patients with stage IIIa HCC combined with main portal vein tumor thrombus;
  • 3: 3. Meets the indications for radical surgical resection;
  • 4: 4. There are clearly defined high-risk recurrence factors (tumor diameter >5 cm, microvascular invasion, satellite lesions, incomplete tumor capsule, alpha-fetoprotein >400 μg/L, etc.;
  • 5: 5. ECOG: 0-1;
  • 6: 6. The functions of major organs have been assessed and meet the requirements for the study treatment;
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  • 7: 7. Has not previously received systematic treatment.
  • 8: 8. Expected survival time ≥ 12 weeks;
  • 9: 9. Baseline blood cell count tests and blood biochemistry must meet the following criteria: white blood cell count ≥ 3.0 × 10^9/L; hemoglobin ≥ 90 g/L; absolute neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 75 × 10^9/L; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g/L;
  • 10: 10. Women of childbearing age must agree to use contraception (such as intrauterine devices, contraceptive pills, or condoms) during the study period and for 6 months after the end of the study; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment in the study and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the study ends.
  • 11: 11. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.

Who cannot join

  • 1: 1. Merge distant metastases;
  • 2: 2. Those allergic to camrelizumab and apatinib mesylate;
  • 3: 3. Previously received systemic or local treatment for liver cancer;
  • 4: 4. Pleural effusion, pericardial effusion, or ascites accompanied by clinical symptoms and judged by the investigator to require frequent drainage;
  • 5: 5. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
  • 6: 6. Active or uncontrolled serious infections (≥CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, and unexplained fever >38.5°C before the first dose;
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  • 7: 7. Those with a history of abuse of psychotropic drugs who are unable to quit, or who have mental disorders;
  • 8: 8.5 Subjects who have had or currently have other malignant tumors requiring active treatment (excluding those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate >90%, carcinoma in situ of the cervix, or carcinoma in situ of the breast);
  • 9: 9. Presence of uncorrectable coagulation disorders;
  • 10: 10. Cardiovascular diseases with significant clinical relevance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class ≥ 2; ventricular arrhythmias requiring medication (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females); left ventricular ejection fraction (LVEF) <50%;
  • 11: 11. Severe liver disease (such as cirrhosis), kidney disease, respiratory system diseases, uncontrolled diabetes, or other types of systemic diseases.
  • 12: 12. Imaging shows that the tumor has invaded major blood vessels, or the researcher judges that during subsequent studies, the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding;
  • 13: 13. Patients with active autoimmune diseases or immunodeficiency, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., shall not be included. Exceptions are as follows: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study.
  • 14: 14. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose >10mg/day of prednisone or other equivalent steroids, and still using within 2 weeks prior to enrollment);
  • 15: 15. Experienced arterial/venous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;
  • 16: 16. The investigator assesses digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or incompletely resected gastrointestinal tumors with active bleeding, or other conditions deemed by the investigator that may cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction).
  • 17: 17. Hypertension not adequately controlled by medication is defined as: systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg;
  • 18: 18. Underwent surgery (excluding biopsy) within 28 days before being enrolled in this study, or the surgical incision has not completely healed;
  • 19: 19. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent form;
  • 20: 20. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
  • 21: 21. According to the researcher's judgment, the patient is considered not suitable for enrollment.

About this study

This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year/2-year/3-year EFS rates.

Being tested
Camrelizumab (anti-PD-1 inhibitor), Apatinib Mesylate Tablets, FOLFOX-HAIC, Surgery Alone
Keywords
HCC
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab (anti-PD-1 inhibitor)Drug

    200 mg administered as intravenous infusion over approximately 30 minutes, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.

  • Apatinib Mesylate TabletsDrug

    250 mg taken orally once daily, every 3 weeks. Given for 2-4 cycles preoperatively and continued postoperatively for at least 6 cycles.

  • FOLFOX-HAICDrug

    One cycle of hepatic arterial infusion (HAIC) using the FOLFOX regimen: Oxaliplatin 85 mg/m² over 0-2 hours, Leucovorin 400 mg/m² over 2-3 hours, 5-FU 400 mg/m² bolus at 3 hours, followed by 5-FU 2400 mg/m² continuous infusion for 44 hours. Administered once during the neoadjuvant phase.

  • Surgery AloneOther

    Patients undergo upfront radical hepatectomy without any perioperative systemic therapy. Postoperative follow-up is conducted according to routine clinical practice.

Study groups in NCT07618546
Study groupRoleWhat they receive
HAIC + Camrelizumab + ApatinibExperimentalNot described
Receives: Drug: Camrelizumab (anti-PD-1 inhibitor); Drug: Apatinib Mesylate Tablets; Drug: FOLFOX-HAIC
Surgery aloneActive comparatorNot described
Receives: Other: Surgery Alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EFS

    Measured: At least 42 months

Secondary outcomes (6)

  1. R0 resection rate

    Measured: 24 months

  2. MPR rate

    Measured: 24 months

  3. OS

    Measured: 24 months

  4. 1-year EFS rate

    Measured: 12 months

  5. 2-year EFS rate

    Measured: 24 months

  6. 3-year EFS rate

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start25 May 2026 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
208 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618546
Sponsor's protocol ID
HOPE-H
Status last verified
Mar 2026
First submitted
25 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Camrelizumab (anti-PD-1 inhibitor), Apatinib Mesylate Tablets and FOLFOX-HAIC in people with HCC - Hepatocellular Carcinoma, run by Henan Cancer 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 11 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 1 Jun 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.

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?

EFS (time frame: At least 42 months). 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 NCT07618546.

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 1 Jun 2026.

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