Clinical trial
Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial
Name
adv-rNPC-RCT-Neo-V1
Description
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
Trial arms
Trial start
2024-02-01
Estimated PCD
2027-06-30
Trial end
2027-06-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
endoscopic surgery
The tumor was resected by endoscopic nasopharyngectomy.
Arms:
The control group, The experimental group
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.
Arms:
The experimental group
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.
Arms:
The experimental group
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.
Arms:
The control group
Size
154
Primary endpoint
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
Eligibility criteria
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 (not confining to the bottom 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}
Updated at
2024-01-31
1 organization
1 product
1 indication
Organization
Eye & ENT Hospital of Fudan UniversityProduct
Toripalimab + GemcitabineIndication
Nasopharyngeal Carcinoma