Reducing radiation for nasopharyngeal cancer after immunotherapy and chemotherapy

De-escalated Radiotherapy for Primary Tumor After Neoadjuvant Therapy With Toripalimab Plus Chemotherapy for Nasopharyngeal Carcinoma

This study is testing if giving less radiation to patients with nasopharyngeal cancer who have responded well to immunotherapy and chemotherapy can help them feel better while reducing side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Toripalimab, prednisone, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06313450 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of de-escalated radiotherapy on patients with stage II-III nasopharyngeal carcinoma who have undergone neoadjuvant therapy with Toripalimab and chemotherapy. The study aims to reduce the radiation dose to the primary tumor site to 60Gy for patients who show significant regression after treatment, potentially lowering the risk of late radiation-induced toxicities. Participants will receive three courses of neoadjuvant gemcitabine plus cisplatin and Toripalimab, followed by the adjusted radiotherapy if their tumor response is favorable. The goal is to improve patient outcomes while minimizing adverse effects associated with conventional radiotherapy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with pathologically confirmed stage II-III nasopharyngeal carcinoma who have not received prior anti-cancer therapy.

Not a fit: Patients over 70 years old, those with active autoimmune diseases, or those with certain viral infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved quality of life for patients by reducing the side effects associated with high-dose radiation.

How similar studies have performed: Previous studies have indicated that de-escalating radiation doses can reduce toxicities, suggesting potential success for this novel approach.

Eligibility criteria

Inclusion Criteria:

1. Pathologically confirmed nasopharyngeal carcinoma, patients who have not received anti-cancer therapy;
2. ECOG performance status score (PS score) 0 or 1.
3. 18-70 years old.
4. Stage II-III except T2N0M0 (AJCC 8th).
5. Neutrophil count ≥ 1.5 × 10\^9/L, hemoglobin ≥ 90 g/L and platelet count ≥ 100 × 10\^9/L.
6. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), bilirubin ≤ 1.5 times ULN; Creatinine clearance ≥ 60 ml/min
7. Patients are required to sign an informed consent form and must be willing and able to comply with the visits, treatment plan, laboratory tests, and other requirements specified in the study protocol

Exclusion Criteria:

Patients will be excluded from the study, if any of the following criteria is met:

1. Over the age of 70 or under the age of 18.
2. HBsAg positive and HBV DNA ≥ 1 × 10\^3 copies/ml
3. HCV antibody positive.
4. Subjects with active, known or suspected autoimmune diseases were excluded from the study. Eligible participants included those with type 1 diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, and skin conditions that do not require systemic therapy such as vitiligo, psoriasis, or alopecia.
5. History of interstitial lung disease;
6. Receiving systemic sex hormones or other immunosuppressive therapy at equivalent doses ≥ 10 mg prednisone/day within 28 days prior to signing informed consent; Subjects with systemic sex hormone doses ≤ 10 mg prednisone/day or inhaled/topical corticosteroids were eligible.
7. Received or about to receive live vaccines within 30 days before signing the informed consent form;
8. Pregnant or lactating women;
9. Other malignancies within 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer;
10. Known previous hypersensitivity to macromolecular protein preparations, or to any component of Toripalimab;
11. Human immunodeficiency virus (HIV) infection.
12. Other conditions that may affect the safety of subjects or trial compliance as judged by the investigator, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infection requiring systemic treatment, mental illness or family and social factors;

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Puyun Ouyang

Conditions Nasopharyngeal Carcinoma; Radiotherapy; Complications; IMMUNOTHERAPY; de-escalated radiotherapy; immunotherapy