Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07277764

Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Nasopharyngeal Carcinoma (NPC) Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Recurrent Nasopharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location status: Recruiting

Location contact

Tianzhu Lu, PhD

CONTACT

[email protected]

13874877311

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

：

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.

Exclusion criteria

：

Distant metastasis at recurrence; active necrosis at recurrence; active/previous autoimmune disease; prior PD-1/PD-L1 therapy; uncontrolled comorbidities; active infections (HBV/HCV/HIV criteria per protocol); interstitial lung disease/pneumonitis; pregnancy/lactation; other protocol-specified exclusions.

Treatment and study plan

High-Low Dose Radiotherapy

Radiation

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.

Primary outcomes

  1. ORR

    Time frame: 3 months after completion of definitive radiotherapy

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

Secondary outcomes

  1. OS

    Time frame: 3 years.

    Overall Survival (OS) - Time from treatment start to death from any cause;

  2. Progression-Free Survival

    Time frame: 3 years.

    Time from treatment start to progression or death;

  3. Safety

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

    Incidence and grade of adverse events per NCI-CTCAE v5.0;

Study contacts

Contact information is provided by the study sponsor or research team.

Jingao Li Prof. Jingao Li, MD

CONTACT

[email protected]

8613970866296

Sponsors and collaborators

Lead sponsor

Jiangxi Provincial Cancer Hospital

Other

Registry information

Official study title

Induction Therapy With High-Low Dose Radiotherapy Combined With Anti-PD-1 Monoclonal Antibody Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma: A Single-Arm, Single-Center Phase II Trial

Acronym: REDEFINE

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.