GNT Induction Treatment in Locally Advanced NPC

September 5, 2023 updated by: Mei Shi, Air Force Military Medical University, China

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

228

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
        • Principal Investigator:
          • Mei Shi, MD
        • Contact:
        • Sub-Investigator:
          • Jian Zang, M.D.,Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gemcitabine, nimotuzumab and toripalimab induction treatment

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
same as before
Other Names:
  • GNT
Active Comparator: gemcitabine and 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.
Drug: gemcitabine, cisplatin
same as before
Other Names:
  • GP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: three weeks after induction therapy
the proportion of patients who achieve complete response and partial response after induction therapy
three weeks after induction therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year overall survival
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: through study completion, an average of 1 year
treatment-related adverse events during treatment and follow-up time
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFMMUChina

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasopharyngeal Carcinoma

Clinical Trials on gemcitabine,nimotuzumab, toripalimab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe