Combining Toripalimab with Chemo-radiotherapy for Advanced Nasopharyngeal Cancer

A Multicenter Randomized Clinical Phase 3 Trial of Toripalimab Plus Concurrent Chemo-radiotherapy vs Concurrent Chemo-radiotherapy Alone for Unresectable Locally Recurrent Nasopharyngeal Carcinoma

This study is testing if adding a new drug called Toripalimab to standard chemo-radiotherapy can help people with advanced nasopharyngeal cancer live longer and feel better.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 226 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation
• Locations: 6 sites (Guangzhou, Guangdong and 5 other locations)
• Trial ID: NCT04453813 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of adding Toripalimab, a PD-1 inhibitor, to concurrent chemo-radiotherapy in patients with unresectable locally recurrent nasopharyngeal carcinoma. Participants are randomly assigned to receive either the combination treatment or chemo-radiotherapy alone. The study aims to compare the efficacy and safety outcomes between these two groups to determine if the addition of PD-1 treatment can reduce disease progression and improve survival rates.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed unresectable locally recurrent nasopharyngeal carcinoma who have not had a recurrence within 12 months of prior radiotherapy.

Not a fit: Patients with resectable nasopharyngeal diseases or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance treatment outcomes for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with PD-1 inhibitors in combination with conventional therapies, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed recurrent nasopharyngeal carcinoma.
2. The recurrence time is more than 12 months from the end of the first course of radiotherapy.
3. Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
4. Subjects must have a measurable disease by CT or MRI per RECIST 1.1 criteria.
5. Karnofsky scale (KPS)≥70.
6. Normal bone marrow function.
7. Normal liver and kidney function:

   1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
   2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
8. Given written informed consent.

Exclusion Criteria:

1. Resectable nasopharyngeal diseases: rT2 (the tumour is confined in the superficial parapharyngeal spacer and is more than 0.5cm from the internal carotid artery) and rT3 (the tumour is confined in the base wall of the sphenoid sinus and is more than 0.5cm from the internal carotid artery and cavernous sinus).
2. The patients are suffering from severe nasopharyngeal necrosis, radiation induced brain injury, and fibrosis of the neck et. al, who are evaluated as unsuitable for secondary radiotherapy by the researchers.
3. Has known allergy to large molecule protein products or any compound of study therapy.
4. Has known subjects with other malignant tumors.
5. Has any active autoimmune disease or history of autoimmune disease.
6. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
7. The laboratory examination value does not meet the relevant standards within 7 days before enrollment
8. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
9. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
10. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
11. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
12. Has a known history of human immunodeficiency virus (HIV).
13. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive
14. Has received a live vaccine within 4 weeks of planned start of study therapy
15. Pregnancy or breast feeding

Where this trial is running

Guangzhou, Guangdong and 5 other locations

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Cancer Center of Guangzhou Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (Not_yet_recruiting)
• Zhongshan People's Hospital — Zhongshan, Guangdong, China (Not_yet_recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Not_yet_recruiting)
• Wuzhou Red Cross Hospital — Wuzhou, Guangxi, China (Recruiting)

Study contacts

• Study coordinator: Ming-Yuan Chen, MD, PhD

Conditions Nasopharyngeal Carcinoma; Chemotherapy; Radiotherapy; PD-1 Treatment