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โ† Trials
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Adjuvant vs Surgery Only in Early-stage Recurrent NPC

RecruitingPhase 3Ages 18 Years - 75 YearsAllEye & ENT Hospital of Fudan University
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In plain words

What the trial is, and whether it could suit you

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. โ‰ฅ6months 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
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What it tests

  • Immunotherapy,Toripalimab Injection
  • Chemotherapy,Gemcitabine based regimen
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Where

7 sites
Eye& ENT Hospital, Fudan University
Shanghai, China
Fujian Medical University Union Hospital
Fuzhou, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China
Changhai Hospital
Shanghai, China
Shanghai Sixth People's Hospital
Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, China
Shenzhen Second People's Hospital
Shenzhen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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