Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC
NCT ID: NCT05350891
Last Updated: 2022-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
77 participants
INTERVENTIONAL
2022-05-08
2026-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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endoscopic surgery combined with adjuvant immunotherapy
endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
Interventions
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endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Chinese Academy of Medical Sciences
OTHER
Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Hongmeng Yu
Principal Investigator, Professor
Principal Investigators
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Hongmeng Yu, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Eye&ENT Hospital,Fudan University
Locations
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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 Municipality, China
Shanghai Zhongshan Hospital,Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jingwu Sun, PhD
Role: primary
Desheng Wang, MD
Role: primary
Haichun Lai, MD
Role: backup
Shaopeng Huang
Role: primary
Yongtian Lu
Role: primary
Jingjin Weng
Role: primary
Jing Ye, MD
Role: primary
Xinsheng Huang
Role: primary
Other Identifiers
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rNPC-SA-Ad-Immuno-V1
Identifier Type: -
Identifier Source: org_study_id
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