Overview

PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
Summary
This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
Innovent Biologics (Suzhou) Co. Ltd.
Treatments:
Antibodies
Cisplatin
Gemcitabine
Criteria
Inclusion Criteria:

1. Patients with histologically confirmed nasopharyngeal carcinoma.

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

3. ECOG performance status ≤1.

4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet
count ≥100×10e9/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 > 65 or < 18.

2. Hepatitis B surface antigen (HBsAg) positive and HBV DNA >1×10e3 copies/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 a known history of interstitial lung disease.

6. 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.

7. Has received a live vaccine within 30 days before informed consent or will receive a
live vaccine in the near future.

8. Is pregnant or breastfeeding.

9. Prior malignancy within 5 years, except in situ cancer, adequately treated
non-melanoma skin cancer, and papillary thyroid carcinoma.

10. Has known allergy to large molecule protein products or any compound of sintilimab.

11. Has a known history of human immunodeficiency virus (HIV) infection.

12. 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.