Overview

PD-1 Antibody Versus Best Supportive Care After Chemoradiation in Locoregionally Advanced Nasopharyngeal Carcinoma

Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is aimed to investigate whether adjuvant PD-1 antibody treatment could improve survival in locoregionally advanced nasopharyngeal carcinoma compared to best supportive care.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Treatments:
Antibodies
Immunoglobulins
Criteria
Inclusion Criteria:

- Patients with histologically confirmed nasopharyngeal carcinoma.

- Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).

- Completed protocol-specified curative chemoradiotherapy, including gemcitabine and
cisplatin induction chemotherapy, intensity-modulated radiotherapy, and concurrent
cisplatin chemotherapy.

- Completion of the last radiation dose within 1 to 14 days before randomization

- Eastern Cooperative Oncology Group performance status ≤1.

- Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet
count ≥100×10e9/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 > 65 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.