MedTrace Logo

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

NCT04072107 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-06-18

No results posted yet for this study

Summary

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.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

sintilimab

Investigate whether capecitabine would be able to improve prognosis in patients at high risk groups

DRUG

Capecitabine

Investigate whether capecitabine would be able to improve prognosis in patients at intermediate risk groups

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    collaborator OTHER

  • Wuzhou Red Cross Hospital

    collaborator OTHER

  • First People's Hospital of Foshan

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ying Sun, M.D. · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-12-01
Completion
2024-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072107 on ClinicalTrials.gov