Clinical trial
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Name
early-rNPC-RCT-adj
Description
Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial
Trial arms
Trial start
2024-02-01
Estimated PCD
2028-06-30
Trial end
2028-06-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Immunotherapy,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.
Arms:
The experimental group
Chemotherapy,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.
Arms:
The experimental group
Size
176
Primary endpoint
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
Eligibility criteria
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 70 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. Previously 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 are not suitable for enrollment
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 176, 'type': 'ESTIMATED'}}
Updated at
2024-01-29
1 organization
2 products
1 indication
Organization
Eye & ENT Hospital of Fudan UniversityProduct
ToripalimabIndication
Nasopharyngeal CarcinomaProduct
Gemcitabine