Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent NPC
Study Details
Study Description
Brief Summary
A Prospective, Single-arm, Multicenter Clinical Study of Transnasal Endoscopic Surgery Combined With Adjuvant Immunotherapy for Recurrent Nasopharyngeal Carcinoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: endoscopic surgery combined with adjuvant immunotherapy
|
Procedure: endoscopic surgery
endoscopic surgery combined with adjuvant immunotherapy with/without chemotherapy
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.]
2 year progression free survival
Secondary Outcome Measures
- Overall survival [From date of enrollment until the date of death from any cause,through study completion,up to 2 years.]
2 year Overall Survival rate
Other Outcome Measures
- 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.]
2 year Local progression free survival
- 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.]
2 year distant metastasis free survival
- Toxicities [From date of enrollment through study completion,up to 2 years.]
Using CTCAE Version5.0 to evaluate incidence of Treatment-Related Adverse Events including treatment related adverse effect and immune related adverse effect.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of USTC(University of Science and Technology of China) | Hefei | Anhui | China | |
| 2 | Fujian Medical University Union Hospital | Fuzhou | Fujian | China | |
| 3 | Fujian Provincial Hospital | Fuzhou | Fujian | China | |
| 4 | Shenzhen Second People's Hospital | Shenzhen | Guangdong | China | |
| 5 | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China | |
| 6 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | |
| 7 | Eye& ENT Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
| 8 | Shanghai Zhongshan Hospital,Fudan University | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Eye & ENT Hospital of Fudan University
- Chinese Academy of Medical Sciences
Investigators
- Principal Investigator: Hongmeng Yu, MD,PHD, Eye&ENT Hospital,Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- rNPC-SA-Ad-Immuno-V1