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NCT07277764: REDEFINE
Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
Phase 2 trial testing High-Low Dose Radiotherapy in Nasopharyngeal Carcinoma (NPC) in 23 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Jiangxi Provincial Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 23 |
| Start date | 10 October 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2029 |
| Sites | 1 location across China |
Drugs / interventions tested
- High-Low Dose Radiotherapy
Conditions studied
- Nasopharyngeal Carcinoma (NPC) — all drugs for Nasopharyngeal Carcinoma (NPC) →
- Recurrent Nasopharyngeal Neoplasms — all drugs for Recurrent Nasopharyngeal Neoplasms →
Sponsor
Jiangxi Provincial Cancer Hospital
Who can join
Adults 18 to 75, any sex, with Nasopharyngeal Carcinoma (NPC) or Recurrent Nasopharyngeal Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07277764
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Nasopharyngeal Carcinoma (NPC)
Currently open trials in the same condition.
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- NCT07340515 — Proton vs Photon IMRT in Locally Advanced Nasopharyngeal Carcinoma: A Phase III Trial · Phase 3 · recruiting
- NCT07328841 — Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinom · Phase 3 · recruiting
- NCT07101744 — Iparomlimab and Tuvonralimab Combined With Nimotuzumab in Recurrent or Metastatic NPC After First-line Treatment Failure · Phase 2 · recruiting
Other Jiangxi Provincial Cancer Hospital trials
Trials by the same sponsor.
- NCT07314255 — The Role of Trop2 in Radioactive Iodine-131 Therapy Sensitivity in Papillary Thyroid Carcinoma · active not recruiting
- NCT07085988 — Effect of Nutritional Management on Patients With Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma · Phase 2 · recruiting
- NCT06770699 — Tertiary Lymphoid Structures in Nasopharyngeal Carcinoma · active not recruiting
- NCT06752239 — Prophylactic Radiotherapy Optimization for Enhanced Thyroid Function Protection in NPC · Phase 3 · recruiting
- NCT06762470 — Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07277764 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangxi Provincial Cancer Hospital
- Last refreshed: 11 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07277764.
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