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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05350891
Other study ID # rNPC-SA-Ad-Immuno-V1
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 8, 2022
Est. completion date May 8, 2026

Study information

Verified date May 2022
Source Eye & ENT Hospital of Fudan University
Contact Xiaole Song, MD
Phone 15821388769
Email jxfxsxl@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 77
Est. completion date May 8, 2026
Est. primary completion date May 8, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Eye & ENT Hospital of Fudan University Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Local progression free survival 2 year Local progression free survival From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years.
Other Distant metastasis free survival 2 year distant metastasis free survival From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years.
Other Toxicities Using CTCAE Version5.0 to evaluate incidence of Treatment-Related Adverse Events including treatment related adverse effect and immune related adverse effect. From date of enrollment through study completion,up to 2 years.
Primary progression free survival 2 year 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.
Secondary Overall survival 2 year Overall Survival rate From date of enrollment until the date of death from any cause,through study completion,up to 2 years.
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