PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiothera… (NCT07528183) | Clinical Trial Compass
Not Yet RecruitingPhase 2
PD-1 Monoclonal Antibody Combined With Gemcitabine and Cisplatin Followed by Selective Radiotherapy for Unresectable Locally Recurrent NPC
86 participantsStarted 2026-04-10
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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