GNT Induction Treatment in Locally Advanced NPC

NCT06026878 | Recruiting Phase 3 DMC

• 1 other identifier: AFMMUChina
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  the proportion of patients who achieve complete response and partial response after induction therapy

  three weeks after induction therapy

Secondary Outcomes (3)

• 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 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 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

Other Outcomes (1)

• adverse events

  through study completion, an average of 1 year

Study Arms (2)

gemcitabine, nimotuzumab and toripalimab induction treatment

EXPERIMENTAL

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.

Drug: gemcitabine,nimotuzumab, toripalimab

gemcitabine and cisplatin

ACTIVE COMPARATOR

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.

Drug: gemcitabine, cisplatin

Interventions

gemcitabine,nimotuzumab, toripalimab DRUG

same as before

Also known as: GNT

gemcitabine, nimotuzumab and toripalimab induction treatment

gemcitabine, cisplatin DRUG

same as before

Also known as: GP

gemcitabine and cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old.
• Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.
• Patients suitable for radical radiochemotherapy.
• ECOG PS score of 0-1.
• 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.
• 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)
• Basically normal liver function: serum total bilirubin ≤1.5×ULN; aspartate aminotransferase (AST) ≤2.5×ULN; alanine aminotransferase (ALT) ≤2.5×ULN.
• Signed written informed consent.

You may not qualify if:

• Patients who have previously undergone immunotherapy or targeted therapy.
• Participated in any other interventional clinical trials within 30 days before screening.
• History of other malignancies (except for cured skin basal cell carcinoma).
• History of primary immunodeficiency.
• Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).
• Known HIV infection, active viral hepatitis, or tuberculosis.
• Major surgery within 90 days before the first dose of the study drug, or planned surgery.
• Allergic to the drugs used in this protocol or their components.
• 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.
• The investigator believes the subject is not suitable for this study.
• Unwilling to participate in this study or unable to sign the informed consent form.
• Live vaccinations within 30 days of dosing.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine; nimotuzumab; toripalimab; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor of department of radiation oncology of XiJing hospital

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)