Camrelizumab for the Treatment of Locally Advanced Nasopharyngeal Carcinoma

Last updated: March 22, 2023
Sponsor: Wei Jiang
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Nasopharyngeal Cancer

Treatment

N/A

Clinical Study ID

NCT05097209
GLMU-07
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 plateletcount ≥80×10e9/L.
  5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit ofnormal (ULN), and bilirubin ≤ 1.5×ULN.
  6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gaultformula).
  7. Patients must be informed of the investigational nature of this study and give writteninformed consent.
  8. Women of childbearing potential (WOCBP) who are sexually active must be willing toadhere to effective contraception during treatment and for 1 year after the last doseof study drug. Men who are sexually active with WOCBP must be willing to adhere toeffective contraception during treatment and for 1 year after the last dose of thestudy drug.

Exclusion

Exclusion Criteria:

  1. Age > 70 or < 18.
  2. Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA >1×10e3copies/ml or 200IU/ml
  3. Hepatitis C virus (HCV) antibody positive
  4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated withreplacement 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 ortopical corticosteroid will be allowed.
  6. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients withadequately 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 alive vaccine in the near future.
  9. Is pregnant or breastfeeding.
  10. Prior malignancy within 5 years, except in situ cancer, adequately treatednon-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, myocardialinfarction, active infection requiring systemic therapy, mental illness ordomestic/social factors, deemed by the investigator to be likely to interfere with apatient's ability to sign informed consent, cooperate and participate in the study, orinterferes with the interpretation of the results.

Study Design

Total Participants: 200
Study Start date:
April 06, 2022
Estimated Completion Date:
April 06, 2026

Study 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.

Connect with a study center

  • Guangxi Nanxishan hospital

    Guilin, Guangxi
    China

    Active - Recruiting

  • Guilin Medical University

    Guilin, Guangxi
    China

    Active - Recruiting

  • Laibin People's Hospital

    Laibin, Guangxi
    China

    Active - Recruiting

  • Linshan people's hospital

    Linshan, Guangxi
    China

    Active - Recruiting

  • Wuzhou Red Cross Hospital

    Wuzhou, Guangxi
    China

    Site Not Available

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