Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

Phase 2

Recruiting

• Conditions: Recurrent Nasopharyngeal Carcinoma

• Registration Number: NCT05350891
• Lead Sponsor: Eye & ENT Hospital of Fudan University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-28
• Status Verified: 2022-05
• Study Start: 2022-05-08
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-10
• Primary Completion: 2026-05-08
• Study Completion: 2026-05-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
progression free survival	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first，through study completion,up to 2 years.	2 year progression free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival	From date of enrollment until the date of death from any cause,through study completion,up to 2 years.	2 year Overall Survival rate

Trial Locations

Locations (8)

The First Affiliated Hospital of USTC(University of Science and Technology of China); 🇨🇳 Hefei, Anhui, China

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Eye& ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Zhongshan Hospital,Fudan University; 🇨🇳 Shanghai, Shanghai, China