PD-1 Inhibitor Plus Chemotherapy Followed by Immediate Versus Selective Re-irradiation for Locally Advanced Recurrent NPC

NCT07332247 | Recruiting Phase 2 DMC

• 1 other identifier: 2025-FXY-205
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II randomized trial evaluates PD-1 inhibitor plus chemotherapy followed by immediate versus selective re-irradiation in locally advanced recurrent nasopharyngeal carcinoma. The study aims to determine whether sequential radiotherapy provides additional survival benefit beyond systemic immunochemotherapy.

Conditions

Nasopharangeal Cancer; Recurrent Nasopharynx Carcinoma

Keywords

Locally Advanced Recurrent Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the time from the date of randomization to the date of death due to any cause.

  3 year

Secondary Outcomes (7)

• Progression free-survival

  3 year

• Progression free-survival 2

  3 year

• Locoregional progression-free survival

  3 year

• Distant progression-free survival

  3 year

• Incidence of Acute and Late Toxicity

  3 year

Study Arms (2)

Selective re-irradiation group

OTHER

PD-1 inhibitor maintenance + Selective re-irradiation: PD-1 inhibitor maintenance therapy:Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1; if progression occurs in the nasopharynx or neck, re-irradiation will be administered and PD-1 maintenance will continue until subsequent progression), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

Radiation: Selective re-irradiation

Immediate re-irradiation group

OTHER

Immediate re-irradiation + PD-1 inhibitor Maintenance: Re-irradiation will be administered Immediately. PD-1 inhibitor maintenance therapy: Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

Radiation: Immediate re-irradiation

Interventions

Selective re-irradiation RADIATION

PD-1 inhibitor maintenance + Selective re-irradiation PD-1 inhibitor maintenance therapy:Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1; if progression occurs in the nasopharynx or neck, re-irradiation will be administered and PD-1 maintenance will continue until subsequent progression), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

Selective re-irradiation group

Immediate re-irradiation RADIATION

Immediate re-irradiation + PD-1 inhibitor Maintenance: Re-irradiation will be administered Immediately. PD-1 inhibitor maintenance therapy: Toripalimab 240 mg IV on day 1 every 3 weeks, or Tislelizumab 200 mg IV on day 1 every 3 weeks, or Camrelizumab 200 mg IV on day 1 every 3 weeks, continued until disease progression (per RECIST v1.1), unacceptable toxicity, patient withdrawal, or a maximum treatment duration of 2 years.

Immediate re-irradiation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years, any gender.
• Local recurrence (with or without regional recurrence) more than one year after radical treatment and unsuitable for surgery.
• Pathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III).
• Achieved complete response (CR) or partial response (PR) after 4-6 cycles of chemotherapy plus PD-1 inhibitor therapy.
• ECOG performance status 0-1.
• Expected survival ≥ 3 months.
• No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent nasopharyngeal carcinoma
• No contraindications to immunotherapy, chemotherapy, or re-irradiation.
• Adequate organ function within 14 days before first dose, defined as:
• Hematology：Hemoglobin ≥ 90 g/L，ANC ≥ 1.5 × 10⁹/L，Platelet count ≥ 100 × 10⁹/L Renal Function：Creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) / eGFR ≥ 60 mL/min Liver Function：Total bilirubin ≤ 1.5 × ULN，AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN in the presence of liver metastases
• INR or PT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range，APTT ≤ 1.5 × ULN, unless on therapeutic anticoagulation and values within therapeutic range.

You may not qualify if:

• Presence of grade 3 or higher late radiation toxicity (excluding skin, subcutaneous tissue, and mucosa) at the time of recurrence
• Prior anti-tumor therapy for recurrent nasopharyngeal carcinoma, including radiotherapy, chemotherapy, surgery, or immunotherapy.
• Prior treatment with PD-1/PD-L1 or CTLA-4 inhibitors.
• History of other malignancies within the past 5 years, except adequately treated basal cell carcinoma, squamous cell skin cancer, or in-situ cervical cancer.
• Active autoimmune disease or history of autoimmune disease requiring systemic treatment (e.g., corticosteroids, immunosuppressants) within the past 2 years, except for stable hypothyroidism, type 1 diabetes mellitus, or resolved childhood asthma/atopy.
• Known history of active pulmonary tuberculosis (TB). Suspected active TB must be excluded by chest X-ray, sputum examination, and assessment of clinical signs and symptoms.
• Hepatitis B: HBsAg positive with peripheral blood HBV DNA ≥ 1000 copies/mL
• Hepatitis C: HCV antibody positive, eligible only if HCV RNA is negative
• HIV infection
• Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, myocardial infarction within 6 months, congestive heart failure ≥ NYHA class II, or serious arrhythmia).
• Interstitial lung disease, non-infectious pneumonitis, or history of ≥ grade 2 pneumonitis.
• Major surgery within 4 weeks before enrollment, or unhealed surgical wound.
• Pregnant or breastfeeding women, or those planning pregnancy during the study period.
• Known allergy or hypersensitivity to study drugs or their excipients.
• Any condition that, in the investigator's judgment, would interfere with trial participation or interpretation of results.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Haiqiang Mai, PhD, MD

CONTACT

+86-020-87343643; maihq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 12, 2026
• Study Start: February 3, 2026
• Primary Completion (Estimated): February 3, 2032
• Study Completion (Estimated): February 3, 2035
• Last Updated: February 4, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)