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GNT Induction Treatment in Locally Advanced NPC

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
gemcitabine,nimotuzumab, toripalimab
gemcitabine, cisplatin
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

gemcitabine, nimotuzumab and toripalimab induction treatment

gemcitabine and cisplatin

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

2-year overall survival
2-year survival rate of patients enrolled in this study
2-year distant metastasis-free survival
2-year distant metastasis-free survival rate of patients enrolled in this study
2-year local regional recurrence-free survival
2-year local regional recurrence-free survival rate of patients enrolled in this study

Full Information

First Posted
August 29, 2023
Last Updated
September 5, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT06026878
Brief Title
GNT Induction Treatment in Locally Advanced NPC
Official Title
Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gemcitabine, nimotuzumab and toripalimab induction treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
gemcitabine and cisplatin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
gemcitabine,nimotuzumab, toripalimab
Other Intervention Name(s)
GNT
Intervention Description
same as before
Intervention Type
Drug
Intervention Name(s)
gemcitabine, cisplatin
Other Intervention Name(s)
GP
Intervention Description
same as before
Primary Outcome Measure Information:
Title
overall response rate
Description
the proportion of patients who achieve complete response and partial response after induction therapy
Time Frame
three weeks after induction therapy
Secondary Outcome Measure Information:
Title
2-year overall survival
Description
2-year survival rate of patients enrolled in this study
Time Frame
From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Title
2-year distant metastasis-free survival
Description
2-year distant metastasis-free survival rate of patients enrolled in this study
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
Title
2-year local regional recurrence-free survival
Description
2-year local regional recurrence-free survival rate of patients enrolled in this study
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
Other Pre-specified Outcome Measures:
Title
adverse events
Description
treatment-related adverse events during treatment and follow-up time
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
Phone
+86-029-84775425
Email
mshifmmu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mei Shi, MD
First Name & Middle Initial & Last Name & Degree
Jian Zang, M.D.,Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

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GNT Induction Treatment in Locally Advanced NPC

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