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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

86 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators