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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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