Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455410
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-06
Brief Title:
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy for Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
GP Plus Adebrelimab Versus GP Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma
Status:
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:
The purpose of this study is to explore the efficacy and safety of neoadjuvant GP chemotherapy plus adebrelimab versus neoadjuvant GP chemotherapy in treating high-risk locoregionally advanced nasopharyngeal carcinoma patients
Detailed Description:
Platinum-based neoadjuvant chemotherapy plus concurrent chemoradiotherapy CCRT is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma NPC Gemcitabine plus cisplatinGP has been demonstrated an effective chemotherapy regimen for NPC patients in previous studies Three cycles of GP neoadjuvant chemotherapy resulted in 10 of complete response rate and GP neoadjuvant chemotherapy added to chemoradiotherapy significantly improved recurrence-free survival 853 vs 765 and overall survival 946 vs 903 among locoregionally advanced NPC patients as compared with concurrent chemoradiotherapy alone Therefore GP has been established as the highest level of evidence-based neoadjuvant chemotherapy regimen in the 2020 National Comprehensive Cancer Network NCCN guidelines Recently immune checkpoint inhibitors such as anti-programmed cell death-1 PD-1 monoclonal antibody has shown promising efficacy in NPC patients Clinical trials have shown objective response rates of 205-34 in patients with recurrent or metastatic NPC patients receiving anti PD-1 monoclonal antibody immunotherapy including pembrolizumab nivolumab camrelizumab and toripalimab GP chemotherapy combined with anti PD-1 antibody were hence considered in treating locoregionally advanced NPC Concurrent radiotherapy might cause T-cell dysfunction and larger-volume elective nodal irradiation might hinder immunotherapy effects by directly depleting memory T cells No survival benefit was observed when PD-1 blockade was added concurrently to the CCRT phase for treating head and neck cancers On the contrary several studies have demonstrated that administration of immunotherapy in the neoadjuvant setting modified the primary tumor into an antigen source for T-cell expansion and priming thereby resulting in stronger effects than those of adjuvant therapy Currently there were 3 trials exploring the addition of immunotherapy to chemoradiotherapy the preliminary results of which were recently published These trials had different trial designs with two trials utilized anti PD-1 inhibitors in all treatment phases including neoadjuvant concurrent and adjuvant phases The third trial which was conducted by our team gave anti PD-1 inhibitor only in the neoadjuvant phase and promising efficacy was observed in our study
Adebrelimab is a recombinant humanized IgG4 monoclonal antibody with specificity for PD-L1 In a phase III clinical trial of extensive stage small-cell lung cancer the addition of adebrelimab significantly improved the median overall survival compared with the control group 153 vs 128HR 072 P00017 So we hypothesize that GP neoadjuvant chemotherapy combined with adebrelimab could further improve the survival of patients with high-risk locoregionally advanced NPC diagnosed with T4 or N2-3 disease Therefore we designed this phase II multi-center randomized controlled trial to evaluate whether GP neoadjuvant chemotherapy combined with adebrelimab plus cisplatin-based CCRT improve the complete response rate of high-risk locoregionally advanced NPC patients compared with GP neoadjuvant chemotherapy plus CCRT
Adebrelimab is a recombinant humanized IgG4 monoclonal antibody with specificity for PD-L1 In a phase III clinical trial of extensive stage small-cell lung cancer the addition of adebrelimab significantly improved the median overall survival compared with the control group 153 vs 128HR 072 P00017 So we hypothesize that GP neoadjuvant chemotherapy combined with adebrelimab could further improve the survival of patients with high-risk locoregionally advanced NPC diagnosed with T4 or N2-3 disease Therefore we designed this phase II multi-center randomized controlled trial to evaluate whether GP neoadjuvant chemotherapy combined with adebrelimab plus cisplatin-based CCRT improve the complete response rate of high-risk locoregionally advanced NPC patients compared with GP neoadjuvant chemotherapy plus CCRT
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