Clinical trial NCT05011227: Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma
Official title: A Prospective, Single-arm, Multi-center Clinical Study of Camrelizumab and Chemotherapy Combined With Endoscopic Surgery in the Treatment of Recurrent Nasopharyngeal Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Nasopharyngeal Carcinoma
Keywords: endoscopic surgery
Inductive chemotherapy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
First posted: 2021-08-18
Enrollment: 100
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: To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed recurrent nasopharyngeal carcinoma
* American Joint Committee on Cancer recurrent rT2(recurrent T2)(including deep parapharyngeal space), recurrent T3, recurrent 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 massive hemorrhage risk recently
* No distant metastasis
* ≥6 months from initial radiotherapy to recurrence
* Radical radiation only once
* Sufficient organ function
* Eastern Cooperative Oncology Group score 0-2

Exclusion Criteria:

* With a history of allergic to platinum drugs and similar compounds
* Evidence of distant metastasis or radiation encephalopathy or leptomeningeal 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: Overall Survival
timeFrame: From date of first treatment until the date of death from any cause, up to 4 years.
Secondary outcomes:
measure: Local recurrence free survival
timeFrame: From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
measure: Progression free survival
timeFrame: From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
measure: Rate of negative margin
timeFrame: At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
measure: distant metastasis free survival
timeFrame: From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
measure: pathologic complete remission
timeFrame: At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.
Other outcomes:
measure: quality of life-（EORTC QLQ) - C30 version3.0
timeFrame: From date of first treatment to the end of study, at each visit, up to 4 years.
measure: quality of life-（EORTC QLQ) - H&N35
timeFrame: From date of first treatment to the end of study, at each visit, up to 4 years.
measure: adverse effect
timeFrame: From date of first treatment to the end of study, up to 4 years.
measure: immune related adverse effect
timeFrame: From date of first treatment to the end of study, up to 4 years.
Locations:
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: