GNT Induction Treatment in Locally Advanced NPC

Phase 3

Recruiting

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: gemcitabine,nimotuzumab, toripalimab; Drug: gemcitabine, cisplatin

• Registration Number: NCT06026878
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-29
• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted QC: 2023-09-05
• Last Update Submitted: 2023-09-05
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Primary Completion: 2025-09-30
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 228

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gemcitabine, nimotuzumab and toripalimab induction treatment	gemcitabine,nimotuzumab, toripalimab	Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 every 3 weeks for two cycles. nimotuzumanb 400mg every 3 weeks for two cycles. toripalimab 240mg every 3 weeks for two cycles.
gemcitabine and cisplatin	gemcitabine, cisplatin	Gemcitabine at a dose of 1 g per square meter of body-surface area on days 1 and 8 and cisplatin at a dose of 80 mg per square meter on day 1 were administered intravenously once every 3 weeks for two cycles.

Primary Outcome Measures

Name	Time	Method
overall response rate	three weeks after induction therapy	the proportion of patients who achieve complete response and partial response after induction therapy

Secondary Outcome Measures

Name	Time	Method
2-year overall survival	From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months	2-year survival rate of patients enrolled in this study
2-year distant metastasis-free survival	From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months	2-year distant metastasis-free survival rate of patients enrolled in this study
2-year local regional recurrence-free survival	From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months	2-year local regional recurrence-free survival rate of patients enrolled in this study

Trial Locations

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China