Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06467799
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-13
Brief Title:
Neoadjuvant HAIC and PD-1 Plus Adjuvant PD-1 for High-risk Recurrent HCC
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Neoadjuvant Hepatic Arterial Infusion Chemotherapy Plus Tislelizumab Combined With Adjuvant Tislelizumab in Preventing Postoperative Recurrence for High-risk Hepatocellular Carcinoma a Prospective Single-arm Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Surgical resection is the primary curative treatment for patients with hepatocellular carcinoma HCC with a 5-year overall survival rate of 60-80 post-surgery Therefore guidelines recommend surgical resection as the first-line choice for early to mid-stage HCC CNLC stages IA-IIA or BCLC stages AB patients with well liver reserve function However the high postoperative recurrence rate is the main factor limiting long-term survival in HCC patients with literature reporting recurrence rates exceeding 70 Among these half of the patients experience recurrence within two years post-surgery imposing a heavy burden on patients physical and mental health as well as on societal medical resources Adopting effective treatment to improve surgical curability and reduce postoperative recurrence rates is one of the current research hotspots
Recent studies from the investigators center indicate that hepatic arterial infusion chemotherapy HAIC and immunotherapy can provide definite efficacy for patients with advanced HCC extending their survival time Mechanistically chemotherapy and immunotherapy have synergistic effects tumor cell necrosis induced by chemotherapy can promote immune activation while cytokines and neutralizing antibodies secreted by immune cells can enhance the toxicity of chemotherapeutic drugs
Therefore this study aims to conduct a prospective single-arm phase II clinical study targeting HCC patients with high-risk recurrence factors to evaluate whether neoadjuvant HAIC combined with a PD-1 monoclonal antibody Tislelizumab followed by adjuvant Tislelizumab post-surgery can reduce postoperative recurrence rates in HCC patients The primary endpoint is the 1-year recurrence-free survival RFS rate post-surgery while secondary endpoints include the objective response rate ORR of neoadjuvant therapy the incidence of perioperative complications the incidence of treatment-related adverse events overall survival OS time pathological complete response pCR rate of neoadjuvant therapy and major pathological response MPR of neoadjuvant therapy The investigators aim to comprehensively assess the efficacy and safety of neoadjuvant HAIC plus PD-1 and adjuvant PD-1 in the perioperative treatment of HCC
Recent studies from the investigators center indicate that hepatic arterial infusion chemotherapy HAIC and immunotherapy can provide definite efficacy for patients with advanced HCC extending their survival time Mechanistically chemotherapy and immunotherapy have synergistic effects tumor cell necrosis induced by chemotherapy can promote immune activation while cytokines and neutralizing antibodies secreted by immune cells can enhance the toxicity of chemotherapeutic drugs
Therefore this study aims to conduct a prospective single-arm phase II clinical study targeting HCC patients with high-risk recurrence factors to evaluate whether neoadjuvant HAIC combined with a PD-1 monoclonal antibody Tislelizumab followed by adjuvant Tislelizumab post-surgery can reduce postoperative recurrence rates in HCC patients The primary endpoint is the 1-year recurrence-free survival RFS rate post-surgery while secondary endpoints include the objective response rate ORR of neoadjuvant therapy the incidence of perioperative complications the incidence of treatment-related adverse events overall survival OS time pathological complete response pCR rate of neoadjuvant therapy and major pathological response MPR of neoadjuvant therapy The investigators aim to comprehensively assess the efficacy and safety of neoadjuvant HAIC plus PD-1 and adjuvant PD-1 in the perioperative treatment of HCC
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None