NCT06569498 Neoadjuvant Triple Therapy for Resectable HCC

Trial Parameters

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Brief Summary

This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily join the study and sign the informed consent form. 2. Male or female patients aged between 18 and 75 years. 3. Child-Pugh class A. 4. Indocyanine green 15-minute retention rate (ICGR-15) \< 15%. 5. ECOG performance status 0-1. 6. Diagnosed with hepatocellular carcinoma (HCC) according to the "Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)." 7. BCLC stage A or B, with a single tumor larger than 5 cm or multiple tumors, and considered surgically resectable after multidisciplinary discussion. 8. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (a measurable lesion with a long diameter ≥ 10 mm on CT/MRI scan, and the measurable lesion has not received local treatments such as radiotherapy or cryotherapy). 9. Blood routine: absolute neutrophil count ≥ 1.5 × 10\^9/L, Hb ≥ 8.5 g/L, PLT ≥ 75 × 10\^9/L. 10. No history of severe arrhythmia, heart failure, severe pulmonary ventilation disorders, or s

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