Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-31 @ 3:33 AM
Study NCT ID:
NCT05201859
Status:
RECRUITING
Last Update Posted:
2022-05-06
First Post:
2022-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Sintilimab Plus Capecitabine in Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
A Randomized, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Sintilimab Plus Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Status:
RECRUITING
Status Verified Date:
2022-05
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:
This randomized clinical trial determining whether Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of NPC patients with unfavorable response to induction chemotherapy. Patients whose plasma EBV DNA\> 0 copy/mL or SD/PD according to RECIST1.1 after two cycles induction chemotherapy will have concurrent chemoradiotherapy. MRI, CT and EBV DNA will be assessed before the end of radiotherapy. After concurrent chemoradiotherapy, eligible patients will be randomized to receive either adjuvant Sintilimab plus Capecitabine or Capecitabine alone.
Detailed Description:
Currently, although NCCN (National Comprehensive Cancer Network) guidelines recommend induction chemotherapy combined with concurrent chemoradiotherapy as IIA level-evidenced treatment for nasopharyngeal carcinoma (NPC), there are still about 20-30% of patients with NPC who experienced recurrence and metastasis after radical treatment.
Our previous results showed that patients with plasma Epstein-Barr virus (EBV) DNA \> 0 copy/mL or stable disease/progressive disease (SD/PD) after induction chemotherapy had a significantly higher risk of disease progression than patients with plasma EBV DNA=0 copy/mL and complete response/partial response (CR/PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). As for these high-risk patients, the urgent clinical problem to be solved is whether increased adjuvant treatment intensity after concurrent chemoradiotherapy can improve their survival rates.
The addition of adjuvant capecitabine to chemoradiotherapy significantly improved survival in patients with NPC, with a manageable safety profile. Sintilimab is a humanized monoclonal antibody against programmed death 1(PD-1). Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Several prospective studies have shown that anti-PD-1 monoclonal antibody combined with chemotherapy had a synergistic effect.
Based on this, this randomized clinical trial determining whether adjuvant Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of patients with unfavorable response to induction chemotherapy and may provide new evidence for individualized comprehensive treatment of NPC patients.
Our previous results showed that patients with plasma Epstein-Barr virus (EBV) DNA \> 0 copy/mL or stable disease/progressive disease (SD/PD) after induction chemotherapy had a significantly higher risk of disease progression than patients with plasma EBV DNA=0 copy/mL and complete response/partial response (CR/PR), according to Response Evaluation Criteria in Solid Tumors (RECIST). As for these high-risk patients, the urgent clinical problem to be solved is whether increased adjuvant treatment intensity after concurrent chemoradiotherapy can improve their survival rates.
The addition of adjuvant capecitabine to chemoradiotherapy significantly improved survival in patients with NPC, with a manageable safety profile. Sintilimab is a humanized monoclonal antibody against programmed death 1(PD-1). Anti-PD-1 monoclonal antibody showed efficacy and safety in previous studies, however, the efficacy of immunotherapy alone was limited. Several prospective studies have shown that anti-PD-1 monoclonal antibody combined with chemotherapy had a synergistic effect.
Based on this, this randomized clinical trial determining whether adjuvant Sintilimab plus Capecitabine versus Capecitabine alone can improve the progression-free survival rate of patients with unfavorable response to induction chemotherapy and may provide new evidence for individualized comprehensive treatment of NPC patients.
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?: