Comparing adjuvant therapy to surgery alone for early-stage recurrent nasopharyngeal carcinoma

Adjuvant Therapy Versus Endoscopic Surgery Alone in Early-stage Recurrent Nasopharyngeal Carcinoma: A Multicenter Randomized Controlled Trial

This study is testing if adding chemotherapy and immunotherapy after surgery helps people with early-stage recurrent nasopharyngeal carcinoma do better than just having surgery alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, prednisone
• Locations: 7 sites (Shanghai, Shanghai Municipality and 6 other locations)
• Trial ID: NCT06228079 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of adjuvant therapy, including chemotherapy and immunotherapy, compared to surgery alone in patients with early-stage recurrent nasopharyngeal carcinoma. Participants are randomly assigned to either receive adjuvant treatment after endoscopic surgery or to be monitored without additional therapy. The study aims to enroll 176 patients across multiple centers, ensuring a robust analysis of treatment outcomes. The trial is designed to be open-label with evaluator blinding to minimize bias in outcome assessment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of early-stage recurrent nasopharyngeal carcinoma who have undergone endoscopic surgery.

Not a fit: Patients with uncontrolled illnesses, distant metastasis, or those who have participated in other interventional trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with early-stage recurrent nasopharyngeal carcinoma, potentially improving survival rates and quality of life.

How similar studies have performed: Other studies have shown promise in using adjuvant therapies for similar conditions, suggesting that this approach may be beneficial.

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 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

Where this trial is running

Shanghai, Shanghai Municipality and 6 other locations

• Eye& ENT Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, China (Not_yet_recruiting)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, China (Recruiting)
• Changhai Hospital — Shanghai, China (Recruiting)
• Shanghai Sixth People's Hospital — Shanghai, China (Not_yet_recruiting)
• Shanghai Zhongshan Hospital — Shanghai, China (Not_yet_recruiting)
• Shenzhen Second People's Hospital — Shenzhen, China (Not_yet_recruiting)

Study contacts

• Principal investigator: Hongmeng Yu — Eye& ENT Hospital, Fudan University
• Study coordinator: Xiaole Song, MD

Conditions Recurrent Nasopharyngeal Carcinoma