NCT06235203 Neoadjuvant vs Adjuvant in Locally Advanced Recurrent NPC
| NCT ID | NCT06235203 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Recurrent Nasopharyngeal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 154 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 154 participants in total. It began in 2024-07-09 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 (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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06235203 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Recurrent Nasopharyngeal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06235203 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 154 participants.
Is NCT06235203 currently recruiting?
Yes, NCT06235203 is actively recruiting participants. Contact the research team at jxfxsxl@163.com for enrollment information.
Where is the NCT06235203 trial being conducted?
This trial is being conducted at Shanghai, China, Fuzhou, China, Nanning, China, Shanghai, China and 3 additional locations.
Who is sponsoring the NCT06235203 clinical trial?
NCT06235203 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 154 participants.