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RECRUITINGPhase 3INTERVENTIONAL

Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

A multicenter randomized controlled study of surgery combined with neoadjuvant and adjuvant therapy for locally advanced recurrent nasopharyngeal carcinoma in comparison to surgery combined with adjuvant therapy

Who May Be Eligible (Plain English)

Who May Qualify: 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition; 3. Cervical lymph node metastasis can be controlled locally; 4. Aged 18 to 75 years; 5. willing to sign a consent form forms signed to participate in the trial; 6. Without distant metastasis; 7. ≥6months from the accomplishment of radical radiation to recurrence 8. previously only 1 course of radiotherapy; 9. Sufficient organ function; 10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy. Who Should NOT Join This Trial: 1. Participate in other interventional clinical trials; 2. Uncontrolled illnesses that interfere with the 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, etc.); 4. Any contradiction to surgery; 5. With serious autoimmune conditions (where your immune system attacks your own body); 6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration; 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 not suitable for enrollment Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Pathologically diagnosed with recurrent nasopharyngeal carcinoma; 2. Resectable disease staging rT2 (deep parapharyngeal space, or distance to the internal carotid ≤5mm) or rT3 (excluding the lesions confined to the basal wall of sphenoid sinus), rT4, according to AJCC 8th edition; 3. Cervical lymph node metastasis can be controlled locally; 4. Aged 18 to 75 years; 5. Informed consent forms signed to participate in the trial; 6. Without distant metastasis; 7. ≥6months from the accomplishment of radical radiation to recurrence 8. previously only 1 course of radiotherapy; 9. Sufficient organ function; 10. ECOG score 0-2 and can tolerate surgery,chemotherapy and immunotherapy. Exclusion Criteria: 1. Participate in other interventional clinical trials; 2. Uncontrolled illnesses that interfere with the 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, etc.); 4. Any contradiction to surgery; 5. With serious autoimmune disease; 6. The patient is currently using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive effects (dosage\>10mg/day prednisone or other glucocorticoids), and continues to use them within 2 weeks before the first administration; 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 not suitable for enrollment

Treatments Being Tested

PROCEDURE

endoscopic surgery

The tumor was resected by endoscopic nasopharyngectomy.

DRUG

Neoadjuvant therapy,Toripalimab Injection and Gemcitabine based therapy

Two courses of Toripalimab Injection and two courses of Toripalimab Injection and Gemcitabine based chemotherapy were given before endoscopic surgery.

DRUG

Adjuvant therapy in experimental group,Toripalimab Injection and Gemcitabine based therapy

Eight courses of Toripalimab Injection and two to four courses of chemotherapy, or until unacceptable side effects.

DRUG

Adjuvant therapy in control group,Toripalimab Injection and Gemcitabine based therapy

Ten courses of Toripalimab Injection and four to six courses of chemotherapy,or until unacceptable side effects.

Locations (7)

Eye& ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, 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