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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Eye& ENT Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• The People's Hospital of Guangxi Zhuang Autonomous Region
  Nanning, China Recruiting
• Changhai Hospital
  Shanghai, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, China Not yet recruiting
• Shanghai Sixth People's Hospital
  Shanghai, China Not yet recruiting
• Shanghai Zhongshan Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Principal investigator: Hongmeng Yu — Eye& ENT Hospital, Fudan University
• Study coordinator: Xiaole Song, MD
• Email: jxfxsxl@163.com
• Phone: +8621 64377134

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Low-temperature plasma radiofrequency ablation versus high-frequency electrocautery resection for localized recurrent nasopharyngeal carcinoma

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• Using Toripalimab with Chemoradiotherapy for Recurrent Nasopharyngeal Carcinoma

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• Combining PD-1 antibody with chemoradiotherapy for recurrent nasopharyngeal carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.