Comparing neoadjuvant and adjuvant therapies for 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 multicenter randomized controlled study investigates the effectiveness of neoadjuvant therapy combined with surgery versus adjuvant therapy following surgery in patients with locally advanced recurrent nasopharyngeal carcinoma. Eligible participants will be randomly assigned to either the experimental group, receiving neoadjuvant therapy before surgery, or the control group, receiving adjuvant therapy after surgery. Both groups will undergo endoscopic surgery and receive chemotherapy and immunotherapy as part of their treatment regimen. The study aims to determine which approach yields better outcomes for patients.

Why it matters

Who can join: the full rules

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

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
• Fujian Medical University Union Hospital
  Fuzhou, China Not yet recruiting
• Changhai Hospital
  Shanghai, China Not yet recruiting
• Shanghai Sixth People's Hospital
  Shanghai, China Not yet recruiting
• Shanghai Zhongshan Hospital
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Xiaole Song
• 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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• Comparing adjuvant therapy to surgery alone for early-stage recurrent nasopharyngeal carcinoma

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• Adding a new drug to immunotherapy for advanced nasopharyngeal cancer

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  Recruiting at 83 sites Phase 2 National Cancer Institute (NCI) · Dublin, California and 94 other locations · NCT06029270

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

  This trial will see if low-temperature plasma radiofrequency ablation works better than high-frequency electrocautery resection for adults with localized recurrent nasopharyngeal carcinoma.

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• Using Toripalimab with Chemoradiotherapy for Recurrent Nasopharyngeal Carcinoma

  This study is testing if adding a new drug called Toripalimab to standard chemotherapy and radiation can help people with recurrent nasopharyngeal cancer live longer and feel better during treatment.

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

  This study is testing if adding a PD-1 antibody to standard chemoradiotherapy can help people with recurrent nasopharyngeal carcinoma feel better compared to just using chemoradiotherapy alone.

  Recruiting at 5 sites Phase 3 Sun Yat-sen University · Guangzhou, Guangdong and 11 other locations · NCT03907826

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.