Neoadjuvant Triple Therapy for Resectable HCC
NCT Number: NCT06569498
Acronym: TALENP001
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Resectable Hepatocellular Carcinoma
Sponsor: Fujian Provincial Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2026-12-01
Locations: Fujian provincial hospital, Fuzhou, Fujian, 350001, China|First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, 350005, China|Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, 350025, China|Zhongshan Hospital of Xiamen University, Xiamen, Fujian, 361005, China|First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361021, China|Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou, Fujian, 363099, China

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).

Primary Outcome Measures: MPR rate, The proportion of residual viable tumor cells in the tumor bed of the surgically resected specimen ≤10%., Immediately after surgery|Adverse events, Refer to the adverse events related to study medication, including type, incidence, and severity; severity was graded according to NCI CTCAE Version 5.0., From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 12 months.|Operative mortality, Defined as the rate of death occurring in the hospital or within 30 days of surgery., From date of surgery, assessed up to 1 month.|Operative complications, Defined as complications directly related to surgery and graded according to the Clavien-Dindo classification., From date of surgery, assessed up to 12 months.|Reoperation rate, Defined as the percentage of postoperative complications that were resolved by surgical treatment., From date of surgery, assessed up to 12 months.
Secondary Outcome Measures: RFS, The time interval between the date of surgery and the first recurrence, or death from any cause., From date of surgery until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 60 months.|ORR, The proportion of individuals whose best overall response is a complete response (CR) or partial response (PR) according to the mRECIST1.1 criteria., Four weeks after the initiation of medication until the day before surgery|R0 resection rate, The proportion of patients who achieve R0 resection (defined as the rate of negative margins microscopically)., Immediately after surgery|OS, The time interval between the date of surgery and death from any cause., From date of surgery until the date of death from any cause, assessed up to 60 months.