Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma
NCT ID: NCT05097209
Last Updated: 2023-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2022-04-06
2026-04-06
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Camrelizumab arm
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.
Camrelizumab
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.
Gemcitabine
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation
Induction Cisplatin
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
intensity-modulated radiotherapy
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Chemoradiation arm
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.
Gemcitabine
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation
Induction Cisplatin
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
intensity-modulated radiotherapy
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Concurrent cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Interventions
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Camrelizumab
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.
Gemcitabine
Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation
Induction Cisplatin
Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation
intensity-modulated radiotherapy
Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
Concurrent cisplatin
Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Wuzhou Red Cross Hospital
OTHER
Guangxi Nanxishan Hospital
UNKNOWN
Laibin People's Hospital
OTHER
Lingshan people's Hospital
UNKNOWN
Wei Jiang
OTHER
Responsible Party
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Wei Jiang
Director, Department of Radiation Oncology, Principal Investigator, Clinical Professor
Principal Investigators
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Bin Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wuzhou Red Cross Hospital
Yu-fei Pan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangxi Nanxishan Hospital
Yi-xin Su, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lingshan people's Hospital
Jian Zhang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Laibin People's Hospital
Locations
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Guangxi Nanxishan hospital
Guilin, Guangxi, China
Guilin Medical University
Guilin, Guangxi, China
Laibin People's Hospital
Laibin, Guangxi, China
Linshan people's hospital
Linshan, Guangxi, China
Wuzhou Red Cross Hospital
Wuzhou, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Jian Zhang, M.D
Role: primary
Yi-xin Su
Role: primary
Bin Zhang
Role: primary
Other Identifiers
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GLMU-07
Identifier Type: -
Identifier Source: org_study_id
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