Sintilimab Combined With Chemotherapy and Radiotherapy in Newly Diagnosed Metastatic Nasopharyngeal Carcinoma: A Multicenter Study

Sun Yat-sen University1 site in 1 country43 target enrollmentJuly 1, 2022

ConditionsNasopharyngeal Carcinoma

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 43
Locations: 1
Primary Endpoint: PFS
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To explore the progression-free survival rate (progression-free survival, PFS), overall survival (OS), objective response rate(objective response rate, ORR) and safety of patients with Sintilimab + GP chemotherapy combined with radiotherapy for newly diagnosed metastatic NPC.

Registry

clinicaltrials.gov

Start Date

July 1, 2022

End Date

July 1, 2025

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Fang-Yun Xie

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Pathologically diagnosed nasopharyngeal cancer with distant metastasis; not received anticancer treatment.
•ECOG Score (PS score) 0 or
•Neutrophil count \> 1.5\*10\^9/L, hemoglobin \> 90g/L, and platelet count \> 100\*10\^9/L.
•ALT or AST level \< 2.5 times upper normal limit (upper limit of normal, ULN), bilirubin level \< 1.5 times ULN.
•Creatinine clearance level \> 60 ml/min.
•Patients must sign an informed consent and must be willing and able to comply with the visit, treatment protocol, laboratory tests and other requirements specified in the study protocol.
•Pregnant female subjects must agree to use reliable contraception within 1 year from the screening visit to the last Sintilimab administration.

Exclusion Criteria

•Age\> 65 years old or \<18 years old.
•HBsAg positive and HBV DNA\> 10\*10\^3 copy number/ml.
•HCV antibody positive.
•Active, known, or suspected autoimmune diseases. Subjects with type I diabetes, hypothyroidism with only hormone replacement therapy, and skin disease without systemic treatment (such as vitiligo, psoriasis, or alopecia) can be selected.
•A history of interstitial lung disease.
•Received systemic hormone or other immunosuppressive therapy with an equivalent dose of\> 10mg of prednisone per day within 28 days prior to signing the informed consent. Subjects with a systemic hormone dose of 10mg prednisone per day or inhaled / topical corticosteroids may be enrolled.
•Received or will be vaccinated within 30 days before signing the informed consent.
•Pregnancy or breastfeeding women (pregnancy tests should be considered).
•Other malignancies within 5 years, except carcinoma in situ, fully treated non-melanoma skin cancer, and papillary thyroid carcinoma.
•previous allergies to macromolecular protein preparations, or any component of Sintilimab.