Recurrent Nasopharyngeal Carcinoma
Conditions
Brief summary
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
Detailed description
Eligible patients are randomized into the control group and the experimental group. Patients in the experimental group would be administrated 2 courses of neoadjuvant therapy before surgery.After endoscopic surgery, patients would continue to receive 2-4 courses of chemotherapy and 8 courses of immunotherapy. Patients in the control group would firstly receive endoscopic surgery, followed by chemotherapy and immunotherapy. In total, 4 to 6 courses of chemotherapy and 10 courses of immunotherapy would be administrated.
Interventions
PROCEDUREendoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
DRUGNeoadjuvant 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.
DRUGAdjuvant 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.
DRUGAdjuvant 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.
Sponsors
Shenzhen Second People's Hospital
Shanghai Zhongshan Hospital
Shanghai 6th People's Hospital
Changhai Hospital
Fujian Medical University Union Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EFS | 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 | Event free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS | From randomization to recurrence, metastasis or death, up to 1 year | Disease free survival |
| LRFS | From randomization to local recurrence or death, up to 1 year | Local recurrence free survival |
| DMFS | From randomization to distant metastasis or death, up to 1 year | Distant metastasis free survival |
| pCR | Time point of pathological tumor evaluation after sugery, around 2 weeks after sugery | pathologic complete response |
| OS | Time interval of randomization and death of any cause, up to 5 years | Overall Survival |
| DCR | Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year | Disease Control Rate,Proportion of CR, PR and SD in all patients. |
| DoR | First date of response to the date of progression, up to 5 years | 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). |
| 1-and 2-year PFS rate | one- and two-year | one- and two-year progression free survival rate |
| 1-and 2-year OS rate | one- and two-year | one- and two-year overall survival rate |
| ORR | Time point of imaging evaluation before treatment(or randomization) and before surgery,up to 1 year | Objective response rate,Proportion of CR, PR in all patients. |
Countries
China
Contacts
Primary ContactXiaole Song
Outcome results
None listed