Recurrent Nasopharyngeal Carcinoma Clinical Trial
Official title:
Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled 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
Status | Recruiting |
Enrollment | 154 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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 70 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. Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, CTLA-4 monoclonal antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway); 9. History of radioactive particle planting; 10. Vaccination with live vaccine within 4 weeks prior to initial administration or possibly during the study period; 11. Female patients who are at pregnancy or lactation; 12. Other situations that the researchers believe not suitable for enrollment |
Country | Name | City | State |
---|---|---|---|
China | Fujian Medical University Union Hospital | Fuzhou | |
China | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning | |
China | Changhai Hospital | Shanghai | |
China | Eye& ENT Hospital, Fudan University | Shanghai | Shanghai |
China | Shanghai Sixth People's Hospital | Shanghai | |
China | Shanghai Zhongshan Hospital | Shanghai | |
China | Shenzhen Second People's Hospital | Shenzhen |
Lead Sponsor | Collaborator |
---|---|
Eye & ENT Hospital of Fudan University | Changhai Hospital, Fujian Medical University Union Hospital, People's Hospital of Guangxi, Shanghai 6th People's Hospital, Shanghai Zhongshan Hospital, Shenzhen Second People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EFS | Event free survival | From randomization and any events(like:progression or toxic effects precluding surgery;inability to resect all gross disease; progression;surgical complications precluding initiation of adjuvant therapy; recurrence;death) up to 1 year | |
Secondary | OS | Overall Survival | Time interval of randomization and death of any cause, up to 5 years | |
Secondary | DFS | Disease free survival | From randomization to recurrence, metastasis or death, up to 1 year | |
Secondary | LRFS | Local recurrence free survival | From randomization to local recurrence or death, up to 1 year | |
Secondary | DMFS | Distant metastasis free survival | From randomization to distant metastasis or death, up to 1 year | |
Secondary | pCR | pathologic complete response | Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery | |
Secondary | ORR | Objective response rate,Proportion of CR, PR in all patients. | Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year | |
Secondary | DCR | Disease Control Rate,Proportion of CR, PR and SD in all patients. | Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year | |
Secondary | DoR | Duration of response,the time from the first assessment of the tumour as CR or PR to the first assessment of PD or death from any cause (whichever event occurs first). | First date of response to the date of progression, up to 5 years | |
Secondary | 1-and 2-year PFS rate | one- and two-year progression free survival rate | one- and two-year | |
Secondary | 1-and 2-year OS rate | one- and two-year overall survival rate | one- and two-year |
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