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Camrelizumab Combined With Apatinib Mesylate and TACE in the Perioperative Treatment of Hepatocellular Carcinoma

StatusRecruiting
PhasePhase 3
Started2023-01-31
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 31, 2024 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-12-30
Study Status, Study Description, Arms and Interventions v2
InterventionsApatinib Mesylate (Drug), Camrelizumab (Drug), Postoperative TACE treatment (Procedure), Preoperative TACE treatment (Procedure), Radical…→Apatinib Mesylate (Drug), Apatinib Mesylate (Drug), Camrelizumab (Drug), Camrelizumab (Drug), Preoperative TACE treatment (Procedure)…
Study description-37 characters
[...] ment，camrelizumab and apatinib, 2 cycles), radical surgery, postoperative TACE treatment, adjuvant therapy (camrelizumab and apatinib, 6 cycles); in t [...] p, patients will be treated with following: radical surgery,adjuvant postoperativetherapy TACE(camrelizumab treatmentand apatinib, 6 cycles). The primary purpose of this study is to evaluate recurrence2 year event-free survival (RFS)（2y-EFS） of camrelizumab combined with apatinib mesylate in the peri [...] th pathological complete response, event-free survival (EFS), overall survival and 12-months recurrence-freeoverall survival of camrelizumab combined [...]
2024-12-24
Study Identification, Study Status, Outcome Measures v1
Start dateestimated 2022-11→confirmed 2023-01-31
Secondary endpoints7 entries, revised
12 months recurrence Disease-free survival (12 months RFSDFS) SafetyAdverse andevent toleraty(AE)
Primary endpoints1 entry, revised
Recurrence2 year event-free survival (RFS)（2y-EFS）
2022-11-06
Original filing
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.
Trial Details
NCT Number NCT05613478
Lead Sponsor The First Affiliated Hospital with Nanjing Medical University
Collaborators: Jiangsu Hengrui Pharmaceutical Co., Ltd.
Conditions Hepatocellular Carcinoma, Immunotherapy, Preoperative
Enrollment 130 participants
Start Date 2023-01-31
Primary Completion 2025-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-12-31