Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC

NCT05350891 | Recruiting Phase 2

• 1 other identifier: rNPC-SA-Ad-Immuno-V1
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Recurrent Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  From date of enrollment until the date of death from any cause,through study completion,up to 2 years.

Other Outcomes (3)

• 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.

• 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.

• Toxicities

  From date of enrollment through study completion,up to 2 years.

Study Arms (1)

endoscopic surgery combined with adjuvant immunotherapy

EXPERIMENTAL

Procedure: endoscopic surgery

Interventions

endoscopic surgery PROCEDURE

endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy

Also known as: adjuvant immunotherapy, chemotherapy

endoscopic surgery combined with adjuvant immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead
• Chinese Academy of Medical Sciences: collaborator

Study Sites (8)

The First Affiliated Hospital of USTC(University of Science and Technology of China)

Hefei, Anhui, China

NOT YET RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT YET RECRUITING

Eye& ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

RECRUITING

Shanghai Zhongshan Hospital,Fudan University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Endoscopy; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Therapeutics

Study Officials

• Hongmeng Yu, MD,PHD

  Eye&ENT Hospital,Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaole Song, MD

CONTACT

15821388769; jxfxsxl@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 28, 2022
• Study Start: May 8, 2022
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): May 8, 2026
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

CN (8)