NCT05613478 Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma
| NCT ID | NCT05613478 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 130 participants in total. It began in 2023-01-31 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Hepatocellular carcinoma (HCC) is the most common primary liver cancer. Hepatectomy is a curable and effective method. However, the recurrence rate is as high as 50%\~70% in 5 years after surgery. Perioperative treatment with immunotherapy combined with target therapy is expected to improve the patient's prognosis. This study aims to evaluate the efficacy, safety and tolerability of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The primary purpose of this study is to evaluate 2 year event-free survival（2y-EFS） of camrelizumab combined with apatinib mesylate in the perioperative period of hepatocellular carcinoma (CNLC Ib-IIIa). The secondary research purpose is to evaluate the R0 resection rate, the rate of subjects with major pathological response, the rate of subjects with pathological complete response, event-free survival (EFS) and overall survival of camrelizumab combined with apatinib mesylate in the perioperative period of resectable hepatocellular carcinoma. The safety and tolerability is also evaluated.
Eligibility Criteria
Inclusion Criteria: * Volunteer to participate in this study and sign an informed consent form. * Age ≥18 years old, no gender limit. * Hepatocellular carcinoma confirmed by histopathology, cytology or imaging. * CNLC stage Ib (single tumor with diameter ≥8 cm)/IIa/IIb/IIIa hepatocellular carcinoma, except for CNLC IIIa hepatocellular carcinoma combined with main portal vein tumor thrombus；multiple hepatocellular carcinoma was allowed to be treated with surgical excision combined with intraoperative ablation. * Child-Pugh score: A grade (≤6 points). * ECOG PS score: 0-1 points. Exclusion Criteria: * Known intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar cell carcinoma; have other active malignancies other than HCC within 5 years or at the same time. * Currently accompanied by interstitial pneumonia or interstitial lung disease. * Existence of active autoimmune disease or history of autoimmune disease and may relapse. * Patients with active infection, unexplained fever ≥38.5℃ within 1 week before randomization, or baseline white blood cell count \>15\*10\^9/L. * Patients with congenital or acquired immune deficiencies (such as HIV-infected persons). * Those who are known to be allergic to any monoclonal antibodies, anti-angiogenesis targeted drugs or excipients.
Contact & Investigator
Xuehao Wang, professor
STUDY CHAIR
The First Affiliated Hospital with Nanjing Medical University
Frequently Asked Questions
Who can join the NCT05613478 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05613478 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 130 participants.
Is NCT05613478 currently recruiting?
Yes, NCT05613478 is actively recruiting participants. Contact the research team at Wangxh@njmu.edu.cn for enrollment information.
Where is the NCT05613478 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT05613478 clinical trial?
NCT05613478 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Xuehao Wang, professor at The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 130 participants.
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