Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT07154069
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adaptive Immunotherapy for Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-11
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:
1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy.
2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
Detailed Description:
Recent trials have demonstrated that for patients with locoregionally advanced nasopharyngeal carcinoma (NPC), the addition of immnotherapy to standard induction chemotherapy followed by concurrent chemoradiotherapy significantly improves event-free survival (EFS) (NCT03700476 and NCT03427827). However, current trials on immnotherapies lack specific biomarkers for risk stratification and adaptive treatment strategies.
Epstein-Barr virus (EBV) is closely associated with the development of NPC. Cell-free EBV-DNA released by NPC cells can be detected in peripheral blood and has been strongly correlated with patient prognosis. Prospective clinical trials (NCT03855020 and NCT04907370) have confirmed that patients with undetectable EBV-DNA after induction therapy exhibit significantly better EFS compared to those with detectable post-induction EBV-DNA.
Among low-risk patients with undetectable EBV-DNA after induction therapy, the 3-year EFS rate exceeds 90%. However, the combination of immunotherapy with concurrent cisplatin-based chemoradiotherapy also leads to significant treatment-related toxicities, with 74% of patients experiencing grade 3 or higher adverse events. Therefore, there is an urgent need to explore novel treatment strategies aimed at reducing toxicity in this patient population. Recent phase 3 multicenter randomized trials have demonstrated that de-intensification strategies omitting concurrent cisplatin chemotherapy significantly reduce treatment-related toxicities in both early-stage (NCT02633202) and locoregionally advanced NPC (NCT04907370), with reductions in grade 3 or higher adverse events by 29% and 11%, respectively.
Among high-risk patients with positive EBV-DNA after induction therapy, even with the combination of immuotherapy, the 3-year EFS remains suboptimal, ranging from 65% to 80%. There is a critical need for treatment intensification strategies to improve outcomes in this group. A recently completed multicenter, randomized, phase 3 trial (NCT02958111) demonstrated that adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year following standard induction chemotherapy and concurrent chemoradiotherapy significantly improved 3-year EFS from 75.7% to 85.3% in high-risk locoregionally advanced NPC patients, with a manageable toxicity profile.
Therefore, the investigators propose the following scientific hypothesis: in low-risk patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy, radiotherapy alone can reduce the incidence of treatment-related adverse effects, without reducing survival; in high-risk patients with stable disease or detectable serum EBV-DNA, adjuvant capecitabine and immunotherapy can improve survival.
Epstein-Barr virus (EBV) is closely associated with the development of NPC. Cell-free EBV-DNA released by NPC cells can be detected in peripheral blood and has been strongly correlated with patient prognosis. Prospective clinical trials (NCT03855020 and NCT04907370) have confirmed that patients with undetectable EBV-DNA after induction therapy exhibit significantly better EFS compared to those with detectable post-induction EBV-DNA.
Among low-risk patients with undetectable EBV-DNA after induction therapy, the 3-year EFS rate exceeds 90%. However, the combination of immunotherapy with concurrent cisplatin-based chemoradiotherapy also leads to significant treatment-related toxicities, with 74% of patients experiencing grade 3 or higher adverse events. Therefore, there is an urgent need to explore novel treatment strategies aimed at reducing toxicity in this patient population. Recent phase 3 multicenter randomized trials have demonstrated that de-intensification strategies omitting concurrent cisplatin chemotherapy significantly reduce treatment-related toxicities in both early-stage (NCT02633202) and locoregionally advanced NPC (NCT04907370), with reductions in grade 3 or higher adverse events by 29% and 11%, respectively.
Among high-risk patients with positive EBV-DNA after induction therapy, even with the combination of immuotherapy, the 3-year EFS remains suboptimal, ranging from 65% to 80%. There is a critical need for treatment intensification strategies to improve outcomes in this group. A recently completed multicenter, randomized, phase 3 trial (NCT02958111) demonstrated that adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year following standard induction chemotherapy and concurrent chemoradiotherapy significantly improved 3-year EFS from 75.7% to 85.3% in high-risk locoregionally advanced NPC patients, with a manageable toxicity profile.
Therefore, the investigators propose the following scientific hypothesis: in low-risk patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy, radiotherapy alone can reduce the incidence of treatment-related adverse effects, without reducing survival; in high-risk patients with stable disease or detectable serum EBV-DNA, adjuvant capecitabine and immunotherapy can improve survival.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: