Comparing two treatments for advanced nasopharyngeal carcinoma

Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study

This study is testing a new combination treatment for advanced nasopharyngeal cancer to see if it works better than the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Air Force Military Medical University, China (Academic / other)
• Drugs / interventions: immunotherapy, nimotuzumab, toripalimab, chemotherapy
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06026878 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a combination treatment involving gemcitabine, nimotuzumab, and toripalimab against the standard gemcitabine and cisplatin regimen in patients with locally advanced nasopharyngeal carcinoma. Participants will be randomly assigned to one of the two treatment groups to assess the overall response rate. The study focuses on patients who are eligible for radical radiochemotherapy and have measurable lesions according to RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage III-IVB nasopharyngeal carcinoma who are suitable for radical treatment.

Not a fit: Patients with early-stage nasopharyngeal carcinoma or those not suitable for radical radiochemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced nasopharyngeal carcinoma.

How similar studies have performed: Other studies have shown promise with similar combination therapies in treating nasopharyngeal carcinoma, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 75 years old.
2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
3. Patients suitable for radical radiochemotherapy.
4. ECOG PS score of 0-1.
5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count ≥4×10\^9/L; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L.
6. Basically normal renal function: serum creatinine ≤1.5×ULN or creatinine clearance rate (CrCl) \> 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl = (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight (kg) x 1.00 / (72 x Scr mg/dl)
7. Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
8. Signed written informed consent.

Exclusion Criteria:

1. Patients who have previously undergone immunotherapy or targeted therapy.
2. Participated in any other interventional clinical trials within 30 days before screening.
3. History of other malignancies (except for cured skin basal cell carcinoma).
4. History of primary immunodeficiency.
5. Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
6. Known HIV infection, active viral hepatitis, or tuberculosis.
7. Major surgery within 90 days before the first dose of the study drug, or planned surgery.
8. Allergic to the drugs used in this protocol or their components.
9. Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.
10. The investigator believes the subject is not suitable for this study.
11. Unwilling to participate in this study or unable to sign the informed consent form.
12. Live vaccinations within 30 days of dosing.

Where this trial is running

Xi'an, Shaanxi

• Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)

Conditions Nasopharyngeal Carcinoma