NCT07277764 Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
| NCT ID | NCT07277764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangxi Provincial Cancer Hospital |
| Condition | Nasopharyngeal Carcinoma (NPC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 23 participants |
| Start Date | 2025-10-10 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 23 participants in total. It began in 2025-10-10 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07277764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nasopharyngeal Carcinoma (NPC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07277764 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07277764 currently recruiting?
Yes, NCT07277764 is actively recruiting participants. Contact the research team at ndzhlyy0005@ncu.edu for enrollment information.
Where is the NCT07277764 trial being conducted?
This trial is being conducted at Nanchang, China.
Who is sponsoring the NCT07277764 clinical trial?
NCT07277764 is sponsored by Jiangxi Provincial Cancer Hospital. The trial plans to enroll 23 participants.