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Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Nimotuzumab
neoadjuvant chemotherapy and CCRT
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring EBV DNA, camrelizumab, nimotuzumab

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+. Age 18-70 years. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition). Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant. ECOG (Eastern Cooperative Oncology Group) score: 0-1 Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN. Renal function: serum creatinine <1×ULN. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Histologically confirmed keratinizing squamous cell carcinoma (WHO I) Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. Receiving radiotherapy or chemotherapy or targeted therapy previously Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. Severe, uncontrolled medical conditions and infections. At the same time using other test drugs or in other clinical trials. Refusal or inability to sign informed consent to participate in the trial. Emotional disturbance or mental

Sites / Locations

  • Fudan Universtiy Shanghai Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

the combination of camrelizumab and standard treatment

the combination of nimotuzumab and standard treatment

standard treatment

Arm Description

camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.

nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.

the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.

Outcomes

Primary Outcome Measures

Progression-free survival
Defined from date of randomization to date of first documentation of progression or death due to any cause

Secondary Outcome Measures

Overall survival
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Toxicities
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.

Full Information

First Posted
March 6, 2023
Last Updated
March 6, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05772208
Brief Title
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
Official Title
A Multicenter, Randomized Controlled Phase III Trial of Induction Plus Concurrent Chemoradiotherapy Plus Camrelizumab or Nimotuzumab Versus Induction Plus Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
EBV DNA, camrelizumab, nimotuzumab

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
the combination of camrelizumab and standard treatment
Arm Type
Experimental
Arm Description
camrelizumab 200mg q3w 2 cycle combinted with the second and third cycle neoajuvant chemotherapy and camrelizumab 200mg q3w 8 cycle starting one month after concurrent chemo-radiotherapy.
Arm Title
the combination of nimotuzumab and standard treatment
Arm Type
Experimental
Arm Description
nimotuzumab 200mg qw combined with the second and third cycle neoajuvant chemotherapy and nimotuzumab 200mg qw used during chemo-radiotherapy.
Arm Title
standard treatment
Arm Type
Active Comparator
Arm Description
the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
camrelizumab 200mg q3w
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab
Intervention Description
nimotuzumab 200mg qw
Intervention Type
Drug
Intervention Name(s)
neoadjuvant chemotherapy and CCRT
Intervention Description
the second and third neoajuvant chemotherapy with GP regimen (gemcitabine 1g/m2 d1，8 plus cisplatin 75mg/m2 ) concurrent chemotherapy: single cisplatin (80mg/m2) for two cycle definitive radiotherapy for primay lesion and lymph node region.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Defined from date of randomization to date of first documentation of progression or death due to any cause
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined from date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Time Frame
3 years
Title
Toxicities
Description
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+. Age 18-70 years. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer[AJCC] edition). Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant. ECOG (Eastern Cooperative Oncology Group) score: 0-1 Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)< 1.5 times the upper limit of normal value (ULN), total bilirubin <1.0×ULN. Renal function: serum creatinine <1×ULN. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule. Exclusion Criteria: Histologically confirmed keratinizing squamous cell carcinoma (WHO I) Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously. Receiving radiotherapy or chemotherapy or targeted therapy previously Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Patients with significantly lower heart, liver, lung, kidney and bone marrow function. Severe, uncontrolled medical conditions and infections. At the same time using other test drugs or in other clinical trials. Refusal or inability to sign informed consent to participate in the trial. Emotional disturbance or mental
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengrun Du
Phone
+86-15001733593
Email
duchengrun@qq.com
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Centre
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongmei Ying, M.D.
Phone
+8621-64175590
Ext
81400
Email
yinghongmei2011@sina.com

12. IPD Sharing Statement

Learn more about this trial

Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

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