Clinical trial NCT05350891: Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC
Official title: A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Nasopharyngeal Carcinoma
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2022-04-28
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: progression free survival
timeFrame: 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.
Secondary outcomes:
measure: Overall survival
timeFrame: From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
Other outcomes:
measure: Local progression free survival
timeFrame: From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years.
measure: Distant metastasis free survival
timeFrame: From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years.
measure: Toxicities
timeFrame: From date of enrollment through study completion,up to 2 years.
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC(University of Science and Technology of China)
state: Anhui
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shanghai
country: China
facility: Eye& ENT Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital,Fudan University
state: Shanghai
Study officials:
affiliation: Eye&ENT Hospital,Fudan University
name: Hongmeng Yu, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: