Immunotherapy,Toripalimab InjectionChemotherapy,Gemcitabine based regimen
Immunotherapy,Toripalimab Injection: Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Chemotherapy,Gemcitabine based regimen: Patients in the experimental group would be implemented with adjuvant Immunotherapy and chemotherapy after endoscopic surgery. Four to six cycles chemotherapy and 10 cycles immunotherapy,or until unacceptable side effects.
Study summary
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma;
2. Stage rT1 or rT2(superficial parapharyngeal space, distance to internal carotid artery \>5mm)or rT3 (confined to the bottom wall of the sphenoid sinus),according to AJCC 8th edition;
3. Cervical lymph node metastasis can be controlled locally
4. Age 18 to 75 years;
5. Without distant metastasis;
6. Informed consent forms signed;
7. ≥6months from the accomplishment of radiation to recurrence
8. previously radiotherapy for only 1 course;
9. ECOG score 0-2 and can tolerate chemotherapy and immunotherapy
10. Sufficient organ function;
11. Undergone endoscopic surgery with negative pathological margin;
Exclusion Criteria:
1. Participation in other interventional clinical trials;
2. Uncontrolled illnesses which will interfere with the ability to undergo therapy;
3. Suffering from another or multiple malignancy within 5 years (excluding fully treated basal cell or skin squamous cell carcinoma, cervical carcinoma in situ);
4. Any contradiction to immune and chemotherapy;
5. With serious autoimmune disease;
6. Currently usage of immunosuppressive agents or systemic glucocorticoid therapy (dosage\>10mg/day prednisone or other glucocorticoids), and continuing to use them within 2 weeks before the first administration of trial drugs;
7. Severe allergic reactions to other monoclonal antibodies;
8. History of radioactive particle planting;
9. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period;
10. Female patients who are at pregnancy or lactation;
11. Other situations that the researchers believe are not suitable for enrollment
Primary outcome measure(s)
DFS — From date of randomization until the date of first documented recurrence, metastasis or date of death from any cause, whichever came first, assessed up to 24 months Disease free survival
Trial sites (7)
Facility
City
Region
Status
Eye& ENT Hospital, Fudan University
Shanghai
Shanghai Municipality
Recruiting
Fujian Medical University Union Hospital
Fuzhou
China
Not Yet Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
China
Recruiting
Changhai Hospital
Shanghai
China
Recruiting
Shanghai Sixth People's Hospital
Shanghai
China
Not Yet Recruiting
Shanghai Zhongshan Hospital
Shanghai
China
Not Yet Recruiting
Shenzhen Second People's Hospital
Shenzhen
China
Not Yet Recruiting
More Eye & ENT Hospital of Fudan University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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