Recurrent Nasopharyngeal Carcinoma
Conditions
Brief summary
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Detailed description
This study is an open-label, multicentered, evaluator-blinded , randomized clinical trial. Patients with early-stage recurrent nasopharyngeal carcinoma were randomized into the control group and the experimental group. Patients in the control group would go through observation and follow-up after recurrent endoscopic surgery, while patients in the experimental group would be treated with adjuvant therapy such as chemotherapy and immunotherapy. A total of 176 subjects are required, with 88 patients in the control group and 88 patients in the experimental group.
Interventions
DRUGImmunotherapy,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.
DRUGChemotherapy,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.
Sponsors
Shanghai Zhongshan Hospital
Shanghai 6th People's Hospital
Changhai Hospital
Fujian Medical University Union Hospital
People's Hospital of Guangxi Zhuang Autonomous Region
Shenzhen Second People's Hospital
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From randomization to death of any cause,assessed up to 60 months | Overall Survival |
| LRFS | From randomization to local recurrence or death,assessed up to 24 months | Local recurrence free survival |
| DMFS | From randomization to distant metastasis or death, assessed up to 24 months | Distant metastasis free survival |
| 1-and 2-year DFS rate | end of 1st year, end of 2nd year | one- and two-year disease free survival |
| 1-and 2-year OS rate | end of 1st year, end of 2nd year | one- and two-year overall survival rate |
Countries
China
Contacts
Primary ContactXiaole Song, MD
Backup ContactYuting Lai
Outcome results
None listed