Using Toripalimab with Chemoradiotherapy for Recurrent Nasopharyngeal Carcinoma

Toripalimab in Combination With Concurrent Chemoradiotherapy for Local-regional Recurrent Nasopharyngeal Carcinoma: a Phase 3, Multicentre, Randomised Controlled Trial

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.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Cancer Hospital of Guangxi Medical University (other)
• Drugs / interventions: triplezumab, prednisone, Toripalimab, radiation
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT04376866 on ClinicalTrials.gov

What this trial studies

This phase 3, multicentre, randomised controlled trial investigates the effectiveness and toxicity of the PD-1 antibody Toripalimab when combined with concurrent cisplatin chemoradiotherapy in patients with locoregionally recurrent nasopharyngeal carcinoma. The study aims to improve survival rates and reduce treatment-related toxicity in patients who have experienced local-regional recurrence of this cancer. Participants will be randomly assigned to receive either the combination treatment or cisplatin chemoradiotherapy alone. The trial is particularly focused on patients with specific staging and performance status criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with newly confirmed recurrent nasopharyngeal carcinoma and satisfactory performance status.

Not a fit: Patients over 65 years old or those with active autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival outcomes and reduce side effects for patients with recurrent nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promising results with PD-1 antibodies in treating recurrent/metastatic nasopharyngeal carcinoma, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Patients with newly histologically confirmed recurrent nasopharyngeal carcinoma, or Two or more image examinations (MRI, and PET-CT) show the recurrent tumor
2. staged as rT3-4N0-1M0或rT1-4N2-3M0 （according to the 8th AJCC edition）
3. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1
4. Neutrophil ≥ 1.5×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
5. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 1.5×ULN)
6. With normal renal function test ( creatinine clearance ≥60 ml/min)
7. sign an "informed consent form
8. Male and no pregnant female

Exclusion Criteria:

1. Age older than 65, or younger than 18 years old
2. Hepatitis B surface antigen (HBsAg) positive and HBV-DNA ≥200IU/ml, or 1000cps/ml.
3. Patients with positive HCV antibody.
4. Active, known or suspected autoimmune disease; Type I Diabetes, hypothyroidism those only need hormone replacement therapy, and skin disease (leukoderma, psoriasis, alopecia et al) who don't need systemic therapy can recruit.
5. History of interstitial lung disease
6. Equivalent dose more than prednisone 10mg/d or other immunosuppressive treatments within 28 days prior to signing the informed consent.
7. Receive or will receive live vaccine within 30 days prior to signing the informed consent.
8. Women of child-bearing potential who are pregnant or breastfeeding.
9. Suffered from malignant tumors, except the carcinoma in situ, papillary thyroid carcinoma, or skin cancer (non- melanoma) within five years.
10. Hypersensitivity to macromolecular protein, or to any component of triplezumab.
11. HIV positive.
12. Severe, uncontrolled medical conditions and infections.
13. Other diseases which may influence the safety or compliance of the clinical trial, such as heart failure with symptom, unstable angina, myocardial infarction, active infections those need systemic therapy, mental illness, or their family and society factors.

Where this trial is running

Nanning, Guangxi

• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (RECRUITING)

Study contacts

• Principal investigator: Song Qu, PhD — Principal Investigator
• Study coordinator: Song Qu, PhD

Conditions: Recurrent Nasopharyngeal Carcinoma, Toripalimab, Concurrent chemoradiotherapy