Surgery and Immunotherapy for Recurrent Nasopharyngeal Cancer

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

This study is testing if combining surgery with immunotherapy can help people with recurrent nasopharyngeal cancer feel better and improve their outcomes.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 8 sites (Hefei, Anhui and 7 other locations)
• Trial ID: NCT05350891 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transnasal endoscopic surgery combined with adjuvant immunotherapy for patients with recurrent nasopharyngeal carcinoma. It is a prospective, single-arm, multicenter study that aims to assess the surgical removal of tumors and the subsequent immunotherapy treatment. Eligible participants will undergo surgery followed by immunotherapy to evaluate the potential improvement in outcomes for this challenging condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed recurrent nasopharyngeal carcinoma that can be surgically removed.

Not a fit: Patients with evidence of distant metastasis or leptomeningeal disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with recurrent nasopharyngeal carcinoma.

How similar studies have performed: While similar approaches combining surgery and immunotherapy have shown promise in other cancers, this specific combination for recurrent nasopharyngeal carcinoma is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.
* AJCC rT1-T4 which can be surgically removed.
* Age ≥18 years old.
* Informed consent signed.
* With or without lymph node metastasis, which can be surgically removed.
* No distant metastasis.
* ≥6 months from the end of initial radiotherapy to recurrence.
* Sufficient organ function a)Hematology: white blood cells ≥3.0 x 109/L, absolute neutrophil count ≥1.5x 109/L, hemoglobin ≥80 g/L, platelets ≥100 x 109/L. b) Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times the ULN c) International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN. d) Renal function: serum creatinine ≤ 1.5 times ULN.
* ECOG score 0-2. general physical condition can tolerate general anesthesia surgery, chemotherapy, and immunotherapy.

Exclusion Criteria:

* Evidence of distant metastasis or leptomeningel disease (LMD).
* Have received radioactive seed implantation in the treatment area.
* Suffer from uncontrolled disease which could interfere with treatment.
* Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.).
* The patient has surgical contraindications: such as severe cardiopulmonary disease, coagulation dysfunction and so on.
* The patients have autoimmune diseases.
* The patient is using immunosuppressive agents or systemic glucocorticoid to achieve the purpose of immunosuppression (dose\>10mg/day prednisone or other), and continues to use it within 2 weeks before the first administration.
* Severe allergic reaction to other monoclonal antibodies.
* Previously received PD-1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody that acts on T cell co-stimulation or checkpoint pathway) treatment.
* Live vaccines have been inoculated within 4 weeks before the first administration or during the study period.
* The patient has any situation that may hinder study compliance or the safety during the study period.
* Existence of serious neurological or psychiatric diseases, such as dementia and seizures.
* Uncontrolled active infection.
* Pregnant or breastfeeding women.
* Those who have no personal freedom and independent capacity for civil conduct.
* There are other situations that are not suitable for entry into the study.

Where this trial is running

Hefei, Anhui and 7 other locations

• The First Affiliated Hospital of USTC(University of Science and Technology of China) — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Fujian Provincial Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Eye& ENT Hospital, Fudan University — Shanghai, Shanghai, China (RECRUITING)
• Shanghai Zhongshan Hospital,Fudan University — Shanghai, Shanghai, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Hongmeng Yu, MD,PHD — Eye&ENT Hospital,Fudan University
• Study coordinator: Xiaole Song, MD

Conditions: Recurrent Nasopharyngeal Carcinoma