NCT07277764

Brief Summary

This single-arm, single-center phase II trial evaluates the safety and efficacy of a non-continuous radio-immunotherapy strategy for recurrent nasopharyngeal carcinoma (NPC) unsuitable for surgery. Induction consists of three fractions of low-dose radiotherapy (1.5 Gy ×3) plus high-dose boosts (5 Gy ×3 to tumor core with carotid/mucosal sparing) combined with anti-PD-1 (240 mg IV on Day 1 and Day 22). After a 21-28-day interval, definitive IMRT (2 Gy ×28, 5 days/week) is delivered without concurrent immunotherapy to minimize immune damage. Anti-PD-1 maintenance (240 mg IV Q3W) starts within 2 weeks after radiotherapy for up to 12 months or until progression/toxicity. The primary endpoint is ORR at 3 months post-radiotherapy; secondary endpoints include 3-year OS, 3-year PFS, safety (NCI-CTCAE v5.0), and quality of life (EORTC QLQ-C30). Key eligibility: histologically confirmed non-keratinizing NPC (WHO II/III), rT2-rT4, ECOG 0-1, adequate organ function.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
43mo left

Started Oct 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Oct 2025Dec 2029

Study Start

First participant enrolled

October 10, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

2.2 years

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Nasopharyngeal Carcinoma (NPC)Recurrent Nasopharyngeal Neoplasms

Keywords

recurrent NPCre-irradiationhigh-low dose radiotherapyinduction radio-immunotherapyPD-1 inhibitor

Outcome Measures

Primary Outcomes (1)

  • ORR

    Objective Response Rate (ORR) at 3 months post-radiotherapy

    3 months after completion of definitive radiotherapy

Secondary Outcomes (3)

  • OS

    3 years.

  • Progression-Free Survival

    3 years.

  • Safety

    through 12 months of therapy and 3-year follow-up.

Study Arms (1)

Induction High-Low Dose RT + Anti-PD-1 → Definitive RT → Anti-PD-1 Maintenance

EXPERIMENTAL

Induction: LD-RT 1.5 Gy ×3 (D1-D3) + HD boost 5 Gy ×3 to tumor core; Anti-PD-1 240 mg IV on D1 \& D22. Definitive RT: from \~D28, IMRT 2 Gy ×28 (5 days/week) without concurrent IO. Maintenance: Anti-PD-1 240 mg IV Q3W up to 12 months. Early stop if CR at 50 Gy or ulcer occurs per protocol.

Radiation: High-Low Dose Radiotherapy

Interventions

High-Low Dose RadiotherapyRADIATION

Induction LD-RT 1.5 Gy ×3 (full lesion coverage) + HD boost 5 Gy ×3 (tumor core; carotid/mucosa sparing \<3 Gy/fx); followed by definitive IMRT 2 Gy ×28.

Induction High-Low Dose RT + Anti-PD-1 → Definitive RT → Anti-PD-1 Maintenance

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed non-keratinizing NPC (WHO II/III); local (± regional) recurrence ≥1 year after prior radical therapy; surgery-ineligible;
  • rT2-rT4 (AJCC 8th); ECOG 0-1;
  • Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds);
  • Contraception requirements per protocol; signed informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal CarcinomaNasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Central Study Contacts

Jingao Li Prof. Jingao Li, MD

CONTACT

8613970866296ndzhlyy0005@ncu.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 11, 2025

Study Start

October 10, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2029

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)