Combining PD-1 inhibitor with chemotherapy for nasopharyngeal carcinoma

Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma

This study is testing if adding a new drug called Toripalimab to standard chemotherapy can help people with high-risk nasopharyngeal carcinoma get better results from their treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Jiangxi Provincial Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, Toripalimab
• Locations: 7 sites (Fuzhou, Fujian and 6 other locations)
• Trial ID: NCT04557020 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of adding the PD-1 inhibitor Toripalimab to neoadjuvant chemotherapy and concurrent chemoradiotherapy in patients with high-risk nasopharyngeal carcinoma. Participants will be randomly assigned to receive either the combination treatment or standard chemotherapy and chemoradiotherapy alone. The goal is to determine if the addition of the PD-1 inhibitor improves treatment outcomes compared to the standard approach.

Who should consider this trial

Good fit: Ideal candidates are males with newly diagnosed non-keratinizing nasopharyngeal carcinoma staged as T4 or N3 without distant metastasis.

Not a fit: Patients with recurrent or metastatic disease, or those with a history of other malignancies or severe uncontrolled medical conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for patients with high-risk nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in various cancers, suggesting potential success for this approach in nasopharyngeal carcinoma.

Eligibility criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
2. Clinical staged as T4 or N3 （according to the 8th AJCC edition）
3. No evidence of distant metastasis (M0)
4. Male and no pregnant female
5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1
6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
8. Normal renal function test ( creatinine clearance ≥60 ml/min)

Exclusion Criteria:

1. Recurrent or distant metastatic disease.
2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
3. History of radiotherapy or chemotherapy.
4. History of immunodeficiency disease
5. History of organ transplantation
6. Presence of life-threatening illness
7. Uncontrolled hypercalcemia
8. Severe uncontrolled medical conditions or active infectious diseases
9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
10. Pregnant or breastfeeding female
11. Emotional disturbance or mental illness
12. Refusal or inability to sign informed consent

Where this trial is running

Fuzhou, Fujian and 6 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Suizhou Central Hospital — Suizhou, Hubei, China (Recruiting)
• Ganzhou Cancer Hospital — Ganzhou, Jiangxi, China (Recruiting)
• First Affiliated hospital of Gannan Medical University — Guangzhou, Jiangxi, China (Recruiting)
• Jiujiang University Affiliated Hospital — Jiujiang, Jiangxi, China (Recruiting)
• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)
• Pingxiang Peoples' Hospital — Pingxiang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Jingao Li, M.D. — Jiangxi Provincial Cancer Hospital
• Study coordinator: Jingao Li

Conditions Nasopharyngeal Carcinoma