Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma
Phase 2
Recruiting
- Conditions
- Recurrent Nasopharyngeal Carcinoma
- Interventions
- Registration Number
- NCT05011227
- Lead Sponsor
- Eye & ENT Hospital of Fudan University
- Brief Summary
To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camrelizumab and chemotherapy combined with endoscopic surgery Chemotherapy Camrelizumab and chemotherapy combined with endoscopic surgery Camrelizumab and chemotherapy combined with endoscopic surgery Camrelizumab Camrelizumab and chemotherapy combined with endoscopic surgery Camrelizumab and chemotherapy combined with endoscopic surgery endoscopic surgery Camrelizumab and chemotherapy combined with endoscopic surgery
- Primary Outcome Measures
Name Time Method Overall Survival From date of first treatment until the date of death from any cause, up to 4 years. 2 year Overall Survival rate
- Secondary Outcome Measures
Name Time Method Local recurrence free survival From date of first treatment until the date of local recurrence or death from any cause, up to 4 years. the date of first treatment to local failure or death
distant metastasis free survival From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years. the date of first treatment to distant metastasis or death
Progression free survival From date of first treatment until the date of disease progression or death from any cause, up to 4 years. the date of first treatment to the first recording of disease progression or death from any cause.
Rate of negative margin At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years. negative margin rate according to pathology report
pathologic complete remission At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years. pathologic complete remission
Trial Locations
- Locations (7)
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