Camrelizumab and Chemotherapy Combined With Endoscopic Surgery for Recurrent Nasopharyngeal Carcinoma

Recurrent Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05011227
• Other study ID #: rNPC-SA-Neo-Cam-V1
• Status: Recruiting
• Phase: Phase 2
• Start date: August 10, 2021
• Est. completion date: August 10, 2025

Study information

• Verified date: March 2024
• Source: Eye & ENT Hospital of Fudan University
• Contact: Xiaole Song, MD
• Phone: 15821388769
• Email: jxfxsxl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 10, 2025
• Est. primary completion date: August 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Recurrence
• Recurrent Nasopharyngeal Carcinoma

Intervention

Drug:
• Camrelizumab
2 cycles Camrelizumab before endoscopic surgery and one year after
• Chemotherapy
2 cycles Gemcitabine based chemotherapy before endoscopic surgery, with or without after surgery

Procedure:
• endoscopic surgery
standard endoscopic surgery for recurrent nasopharyngeal carcinoma

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 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	quality of life-(EORTC QLQ) - C30 version3.0	using European Organisation for Research and Treatment of Cancer quality of life questionaire(EORTC QLQ) - C30 version3.0. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	From date of first treatment to the end of study, at each visit, up to 4 years.
Other	quality of life-(EORTC QLQ) - H&N35	using European Organisation for Research and Treatment of Cancer quality of life questionaire(EORTC QLQ)- H&N35,All of the scales and single-item measures range in score from 0 to 100. For all the scales and single-items a high score represents a high level of symptomatology or problems.	From date of first treatment to the end of study, at each visit, up to 4 years.
Other	adverse effect	Using CTCAE Version5.0 to evaluate related adverse effect	From date of first treatment to the end of study, up to 4 years.
Other	immune related adverse effect	Using CTCAE Version5.0 to evaluate immune related adverse effect	From date of first treatment to the end of study, up to 4 years.
Primary	Overall Survival	2 year Overall Survival rate	From date of first treatment until the date of death from any cause, up to 4 years.
Secondary	Local recurrence free survival	the date of first treatment to local failure or death	From date of first treatment until the date of local recurrence or death from any cause, up to 4 years.
Secondary	Progression free survival	the date of first treatment to the first recording of disease progression or death from any cause.	From date of first treatment until the date of disease progression or death from any cause, up to 4 years.
Secondary	Rate of negative margin	negative margin rate according to pathology report	At the time of pathology reporting, util the pathology report of last subject was completed, up to 2.5 years.
Secondary	distant metastasis free survival	the date of first treatment to distant metastasis or death	From date of first treatment until the date of distant metastasis or death from any cause, up to 4 years.
Secondary	pathologic complete remission	pathologic complete remission	At the time of pathology reporting,util the pathology report of last subject was completed, up to 2.5 years.