A Multicenter, Randomized, Open-label, Controlled Study of HAIC Combined With Camrelizumab and Ap… (NCT07618546) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
208 participantsStarted 2026-05-25
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.