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Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
Gemcitabine
Induction Cisplatin
intensity-modulated radiotherapy
Concurrent cisplatin
Sponsored by
Wei Jiang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Intensity Modulated Radiotherapy, Camrelizumab

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with histologically confirmed nasopharyngeal carcinoma.
  2. Tumor staged as III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0).
  3. Eastern Cooperative Oncology Group performance status ≤1.
  4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥80g/L and platelet count ≥80×10e9/L.
  5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
  6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
  7. Patients must be informed of the investigational nature of this study and give written informed consent.
  8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

Exclusion Criteria:

  1. Age > 70 or < 18.
  2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml
  3. Hepatitis C virus (HCV) antibody positive
  4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
  5. Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
  6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed.
  7. Has a known history of interstitial lung disease.
  8. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
  9. Is pregnant or breastfeeding.
  10. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
  11. Has known allergy to large molecule protein products or any compound of camrelizumab.
  12. Has a known history of human immunodeficiency virus (HIV) infection.
  13. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.

Sites / Locations

  • Guangxi Nanxishan hospitalRecruiting
  • Guilin Medical UniversityRecruiting
  • Laibin People's HospitalRecruiting
  • Linshan people's hospitalRecruiting
  • Wuzhou Red Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Camrelizumab arm

Chemoradiation arm

Arm Description

Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.

Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.

Outcomes

Primary Outcome Measures

Progress-free survival (PFS)
Calculated from randomization to the date of progression or death from any cause, whichever occurred first.

Secondary Outcome Measures

Overall survival (OS)
Calculated from randomization to the date of death from any cause.
Distant Metastasis-free survival (DMFS)
Calculated from randomization to the date of first distant metastasis.
Locoregional failure-free survival (LRRFS)
Calculated from randomization to the date of locoregional relapse.
Adverse events (AEs) and serious adverse events (SAEs)
Graded according to CTCAE V5.0.

Full Information

First Posted
October 15, 2021
Last Updated
March 22, 2023
Sponsor
Wei Jiang
Collaborators
Wuzhou Red Cross Hospital, Guangxi Nanxishan Hospital, Laibin People's Hospital, Lingshan people's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05097209
Brief Title
Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma
Official Title
Camrelizumab Combined With Induction Chemotherapy and Intensity Modulated Radiotherapy for the Treatment of Locally Advanced Nasopharyngeal Carcinoma:a Randomized, Multicenter, Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
April 6, 2025 (Anticipated)
Study Completion Date
April 6, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Jiang
Collaborators
Wuzhou Red Cross Hospital, Guangxi Nanxishan Hospital, Laibin People's Hospital, Lingshan people's Hospital

4. Oversight

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

5. Study Description

Brief Summary
This trial plans to enroll patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or 3 cycles of induction chemotherapy with gemcitabine and cisplatin and radiation plus Camrelizumab. All patients will receive intensity-modulated radiotherapy (IMRT). Camrelizumab will begin on day 1 of induction chemotherapy every 3 weeks for 3 cycles and continue every 2 weeks for 9 cycles.
Detailed Description
Objectives:To investigate the clinical efficacy of camrelizumab in the treatment of locoregionally-advanced nasopharyngeal carcinoma (LANPC). Outline:Patients with stage III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0) locoregionally-advanced nasopharyngeal carcinoma will be randomized in a 1:1 ratio to experimental arm and active comparator arm. Patients in experimental arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter. Patients in active comparator arm will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Intensity Modulated Radiotherapy, Camrelizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camrelizumab arm
Arm Type
Experimental
Arm Description
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.
Arm Title
Chemoradiation arm
Arm Type
Active Comparator
Arm Description
Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 & 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy in 33 fractions will be given. Concurrent cisplatin of 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT.
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Other Intervention Name(s)
PD-1 antibody
Intervention Description
Camrelizumab 200mg will be given every 3 weeks for 3 cycles started on day 1 of induction chemotherapy and every 2 weeks for 9 cycles thereafter.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gem
Intervention Description
Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation
Intervention Type
Drug
Intervention Name(s)
Induction Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiotherapy
Other Intervention Name(s)
IMRT
Intervention Description
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Intervention Type
Drug
Intervention Name(s)
Concurrent cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Primary Outcome Measure Information:
Title
Progress-free survival (PFS)
Description
Calculated from randomization to the date of progression or death from any cause, whichever occurred first.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Calculated from randomization to the date of death from any cause.
Time Frame
3 years
Title
Distant Metastasis-free survival (DMFS)
Description
Calculated from randomization to the date of first distant metastasis.
Time Frame
3 years
Title
Locoregional failure-free survival (LRRFS)
Description
Calculated from randomization to the date of locoregional relapse.
Time Frame
3 years
Title
Adverse events (AEs) and serious adverse events (SAEs)
Description
Graded according to CTCAE V5.0.
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 histologically confirmed nasopharyngeal carcinoma. Tumor staged as III-IVA (AJCC 8th, included T1-2N2-3 and/or T3-4N0-3 M0). Eastern Cooperative Oncology Group performance status ≤1. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥80g/L and platelet count ≥80×10e9/L. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula). Patients must be informed of the investigational nature of this study and give written informed consent. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug. Exclusion Criteria: Age > 70 or < 18. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3 copies/ml or 200IU/ml Hepatitis C virus (HCV) antibody positive Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia). Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB over 1 year ago will be allowed. Has a known history of interstitial lung disease. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future. Is pregnant or breastfeeding. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma. Has known allergy to large molecule protein products or any compound of camrelizumab. Has a known history of human immunodeficiency virus (HIV) infection. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Jiang, Ph.D.
Phone
+86-773-2882906
Email
weijiang@glmc.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bin Zhang, M.D.
Organizational Affiliation
Wuzhou Red Cross Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yu-fei Pan, M.D.
Organizational Affiliation
Guangxi Nanxishan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yi-xin Su, M.D.
Organizational Affiliation
Lingshan people's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jian Zhang, M.D.
Organizational Affiliation
Laibin People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangxi Nanxishan hospital
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yufei Pan, M.D.
Phone
+8613737740520
Email
23865934@qq.com
Facility Name
Guilin Medical University
City
Guilin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jiang, Ph.D
Phone
+8613788561863
Email
weijiang@glmc.edu.cn
Facility Name
Laibin People's Hospital
City
Laibin
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhang, M.D
Facility Name
Linshan people's hospital
City
Linshan
State/Province
Guangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-xin Su
Facility Name
Wuzhou Red Cross Hospital
City
Wuzhou
State/Province
Guangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Zhang

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

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