NCT04072107: EP-STAR

EPstein-barr Virus DNA Response to Systemic Therapy for Treatment Adaptation in High Risk NPC (EP-STAR)

Status unknown Phase 2 Last updated 18 June 2023

What this trial tests

Phase 2 trial testing sintilimab in Nasopharyngeal Carcinoma in 110 participants. Status unknown.

Timeline

1 June 2020

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	110
Start date	1 June 2020
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across China

Drugs / interventions tested

• sintilimab — full drug profile →
• Capecitabine (capecitabine) — full drug profile →

Conditions studied

• Nasopharyngeal Carcinoma — all drugs for Nasopharyngeal Carcinoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 65, any sex, with Nasopharyngeal Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators aim to investigate whether incorporating on-treatment EBV DNA surveillance for monitoring tumor responses to treatment and for guiding individuliased treatment adaptation can improve prognosis in nasopharyngeal carcinoma patient . For patients with detectable EBV DNA after one cycle of IC, which then drops to undetectable levels during the following IC cycles (intermediate responders/intermediate relapse risk), the investigators aim to investigate whether additional adjuvant metronomic capecitabine would benefit this subgroup. For patients with detectable EBV DNA after three cycles of IC or with EBV DNA bounce during the induction phase (insensitive to IC/high relapse risk), the investigators aim to investigate whether concurrent administration of anti-PD-1 therapy during the following treatment phases (including concurrent phase and adjuvant phase) can benefit this subgroup.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current status and advances of immunotherapy in nasopharyngeal carcinoma.
   Xu JY, Wei XL, Wang YQ, Wang FH. · · 2022 · cited 62× · PMID 35547095 · DOI 10.1177/17588359221096214
2. Enhancing efficacy and reducing toxicity: Therapeutic optimization in locoregionally advanced nasopharyngeal carcinoma.
   Jiang W, Lv JW, Tang LL, Sun Y, et al · · 2024 · cited 15× · PMID 38843843 · DOI 10.1016/j.xcrm.2024.101594
3. Targeting Metabolic Vulnerabilities in Epstein-Barr Virus-Driven Proliferative Diseases.
   Leung NYT, Wang LW. · · 2023 · cited 4× · PMID 37444521 · DOI 10.3390/cancers15133412
4. Epstein-Barr virus dynamics and its prognostic impact on nasopharyngeal cancers in a non-endemic region.
   Ganapathi R, Kumar RR, Thomas KC, Rafi M, et al · · 2022 · cited 3× · PMID 36819809 · DOI 10.3332/ecancer.2022.1479
5. Risk-adaptive therapy guided by dynamic ctDNA in nasopharyngeal carcinoma.
   Lv J, Zheng DX, Liang JH, Zhang N, et al · · 2026 · cited 1× · PMID 41813900 · DOI 10.1038/s41586-026-10244-w
6. Individualised cumulative cisplatin dose for locoregionally advanced nasopharyngeal carcinoma patients based on induction chemotherapy response and tumour volume.
   Lin JY, Lu ZJ, Li SC, Luo DH, et al · · 2024 · PMID 39483137 · DOI 10.1177/17588359241286222