Comparing neoadjuvant and adjuvant therapies for recurrent nasopharyngeal carcinoma

Neoadjuvant-Adjuvant Versus Adjuvant-Only Therapy Combined With Endoscopic Surgery in Advanced Recurrent Nasopharyngeal Carcinoma:A Multicenter Randomized Controlled Trial

This study is testing whether giving treatment before surgery or after surgery helps people with recurrent nasopharyngeal cancer do better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (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: NCT06235203 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with pathologically diagnosed recurrent nasopharyngeal carcinoma that is resectable and without distant metastasis.

Not a fit: Patients with uncontrolled illnesses, multiple malignancies, 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 improve treatment outcomes and survival rates for patients with recurrent nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promise in using neoadjuvant therapies for various cancers, suggesting potential success for this approach in nasopharyngeal carcinoma.

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

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 (Not_yet_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

• Study coordinator: Xiaole Song

Conditions Recurrent Nasopharyngeal Carcinoma