Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

NCT ID: NCT05011227

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2025-08-10

Brief Summary

To explore the effect of Camrelizumab and chemotherapy combining with endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma.

Conditions

Recurrent Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camrelizumab and chemotherapy combined with endoscopic surgery

Camrelizumab and chemotherapy combined with endoscopic surgery

Group Type: EXPERIMENTAL

Camrelizumab

Intervention Type: DRUG

2 cycles Camrelizumab before endoscopic surgery and one year after

Chemotherapy

Intervention Type: DRUG

2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery

endoscopic surgery

Intervention Type: PROCEDURE

standard endoscopic surgery for recurrent nasopharyngeal carcinoma

Interventions

Camrelizumab

2 cycles Camrelizumab before endoscopic surgery and one year after

Intervention Type: DRUG

Chemotherapy

2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery

Intervention Type: DRUG

endoscopic surgery

standard endoscopic surgery for recurrent nasopharyngeal carcinoma

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongmeng Yu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Eye&ENT Hospital,Fudan University

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status: NOT_YET_RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Site Status: NOT_YET_RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status: NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: NOT_YET_RECRUITING

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Shanghai Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Xiaole Song, MD

Role: CONTACT

jxfxsxl@163.com

15821388769

Facility Contacts

Desheng Wang, MD

Role: primary

Haichun Lai, MD

Role: backup

Shaopeng Huang

Role: primary

Yongtian Lu

Role: primary

Jingjin Weng, PhD

Role: primary

Jing Ye, MD

Role: primary

Li Yan, MD

Role: primary

yanl13@fudan.edu.cn

13761720601

Xinsheng Huang

Role: primary

Other Identifiers

rNPC-SA-Neo-Cam-V1

Identifier Type: -

Identifier Source: org_study_id