Nasopharyngeal Carcinoma (NPC)Phase 2REDEFINENCT07277764
Induction High-Low Dose Radiotherapy Plus Anti-PD-1 Followed by Definitive Radiotherapy in Recurrent Nasopharyngeal Carcinoma (Single-Arm Phase II)
A Phase 2 study testing High-Low Dose Radiotherapy in people with Nasopharyngeal Carcinoma (NPC) and Recurrent Nasopharyngeal Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC), Recurrent Nasopharyngeal Neoplasms
- What is being tested?
- High-Low Dose Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2025to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Tianzhu Lu, PhD, 13874877311, lutianzhu2008@163.com
About this study
Official 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
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.
- Being tested
- High-Low Dose Radiotherapy
- Keywords
- recurrent NPC, re-irradiation, high-low dose radiotherapy, induction radio-immunotherapy, PD-1 inhibitor
- Medical subject headings
- Nasopharyngeal Carcinoma, Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: High-Low Dose Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate (ORR) at 3 months post-radiotherapy
Measured: 3 months after completion of definitive radiotherapy
Secondary outcomes (3)
OS
Overall Survival (OS) - Time from treatment start to death from any cause;
Measured: 3 years.
Progression-Free Survival
Time from treatment start to progression or death;
Measured: 3 years.
Safety
Incidence and grade of adverse events per NCI-CTCAE v5.0;
Measured: through 12 months of therapy and 3-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start10 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277764
- Sponsor's protocol ID
- REDEFINE
- Acronym
- REDEFINE
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07277764
- Acronym / sponsor ID
- REDEFINE / REDEFINE
- Keywords
- recurrent NPC, re-irradiation, high-low dose radiotherapy, induction radio-immunotherapy, PD-1 inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction High-Low Dose RT + Anti-PD-1 → Definitive RT → Anti-PD-1 Maintenance | Experimental | Radiation: High-Low Dose RadiotherapyInduction: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Low Dose RadiotherapyInduction 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. | Radiation | Induction High-Low Dose RT + Anti-PD-1 → Definitive RT → Anti-PD-1 Maintenance |
Primary outcome
ORR
Time frame: 3 months after completion of definitive radiotherapy
Objective Response Rate (ORR) at 3 months post-radiotherapy
3 secondary outcomes
OS
Time frame: 3 years.
Progression-Free Survival
Time frame: 3 years.
Safety
Time frame: through 12 months of therapy and 3-year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High-Low Dose Radiotherapy in people with Nasopharyngeal Carcinoma (NPC) and Recurrent Nasopharyngeal Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingao Li Prof. Jingao Li, MD (8613970866296, ndzhlyy0005@ncu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 months after completion of definitive radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.