PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiotherapy for Unresectable Locally Recurrent NPC

NCT07528183 | Not Yet Recruiting Phase 2

• 1 other identifier: B2025-628
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators plan to conduct a multicenter, prospective, single-arm phase II clinical trial of PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy for unresectable locally recurrent nasopharyngeal carcinoma to evaluate the efficacy and safety of PD-1 antibody plus GP chemotherapy followed by sequential selective radiotherapy in patients with unresectable locally recurrent disease who achieve tumor regression after immunochemotherapy, thereby providing evidence-based medical evidence for the treatment of unresectable locally recurrent NPC and improving treatment outcomes for these patients.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• Overall survival

  the time from the date of treatment initiation to the date of death due to any cause.

  3 years

Secondary Outcomes (6)

• Progression free-survival

  3 years

• Locoregional progression-free survival

  3 years

• Distant progression-free survival

  3 years

• Incidence of toxicity

  3 years

• Quality of life (QoL)

  3 years

Study Arms (1)

Selective re-irradiation group

OTHER

Drug: PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy

Interventions

PD-1 monoclonal antibody combined with gemcitabine and cisplatin followed by selective radiotherapy DRUG

1. Gemcitabine + Cisplatin Chemotherapy: Gemcitabine 1000 mg/m² on days 1 and 8 + Cisplatin 80 mg/m² on day 1, every 3 weeks, for 4-6 cycles. PD-1 Monoclonal Antibody Immunotherapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, for 4-6 cycles. 2. PD-1 Maintenance Therapy: Toripalimab 240 mg on day 1, every 3 weeks, or Tislelizumab 200 mg on day 1, every 3 weeks, or Camrelizumab 200 mg on day 1, every 3 weeks, until disease progression (according to RECIST v1.1; if progression occurs in the nasopharynx or neck while metastatic lesions remain well controlled, radiotherapy to the nasopharynx and neck will be given, after which immunotherapy maintenance may continue until further progression), unacceptable toxicity, withdrawal of patient consent, or completion of a cumulative 2 years of treatment.

Selective 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

MeSH Terms

Interventions

Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Design

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

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2032
• Study Completion (Estimated): April 10, 2035
• Last Updated: April 14, 2026

Record last verified: 2026-04