Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

Recurrent Nasopharyngeal Carcinoma Clinical Trial

Official title:

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05350891
• Other study ID #: rNPC-SA-Ad-Immuno-V1
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2022
• Est. completion date: May 8, 2026

Study information

• Verified date: May 2022
• 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

A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 77
• Est. completion date: May 8, 2026
• Est. primary completion date: May 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathology or radiography confirmed recurrent nasopharyngeal carcinoma.

• 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:

• Evidence of distant metastasis or leptomeningel 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
• Recurrent Nasopharyngeal Carcinoma

Intervention

Procedure:
• endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy

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 USTC(University of Science and Technology of China)	Hefei	Anhui
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	Local progression free survival	2 year Local progression free survival	From date of enrollment to local failure or date of death from any cause,through study completion,up to 2 years.
Other	Distant metastasis free survival	2 year distant metastasis free survival	From date of enrollment to distant metastasis or date of death from any cause, through study completion,up to 2 years.
Other	Toxicities	Using CTCAE Version5.0 to evaluate incidence of Treatment-Related Adverse Events including treatment related adverse effect and immune related adverse effect.	From date of enrollment through study completion,up to 2 years.
Primary	progression free survival	2 year progression free survival	From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first,through study completion,up to 2 years.
Secondary	Overall survival	2 year Overall Survival rate	From date of enrollment until the date of death from any cause,through study completion,up to 2 years.