Clinical trial NCT05097209: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: Intensity Modulated Radiotherapy
Camrelizumab
Lead sponsor: Guilin Medical University, China
Sponsor class: OTHER
Collaborators: name: Wuzhou Red Cross Hospital
name: Guangxi Nanxishan Hospital
name: Laibin People's Hospital
name: Lingshan people's Hospital
First posted: 2021-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progress-free survival (PFS)
timeFrame: 3 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Distant Metastasis-free survival (DMFS)
timeFrame: 3 years
measure: Locoregional failure-free survival (LRRFS)
timeFrame: 3 years
measure: Adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 3 years
Other outcomes:
Locations:
city: Guilin
country: China
facility: Guangxi Nanxishan hospital
state: Guangxi
city: Guilin
country: China
facility: Guilin Medical University
state: Guangxi
city: Laibin
country: China
facility: Laibin People's Hospital
state: Guangxi
city: Linshan
country: China
facility: Linshan people's hospital
state: Guangxi
city: Wuzhou
country: China
facility: Wuzhou Red Cross Hospital
state: Guangxi
Study officials:
affiliation: Wuzhou Red Cross Hospital
name: Bin Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Nanxishan Hospital
name: Yu-fei Pan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lingshan people's Hospital
name: Yi-xin Su, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laibin People's Hospital
name: Jian Zhang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: