A Pilot Study of Sintilimab Plus Chemotherapy Followed by Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma

Fudan University1 site in 1 country75 target enrollmentOctober 10, 2019

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsSintilimab plus Chemotherapy

DrugsSintilimab plus Chemotherapy

Overview

Phase: Phase 2
Intervention: Sintilimab plus Chemotherapy
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Fudan University
Enrollment: 75
Locations: 1
Primary Endpoint: Local Control Rate
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of A sintilimab plus chemotherapy followed by definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Registry

clinicaltrials.gov

Start Date

October 10, 2019

End Date

December 31, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Kuai Le Zhao, MD

Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

•Written informed consent
•Aged 18-75 years
•Histologically confirmed esophageal squamous cell carcinoma
•Clinical stages T3-4N0M0 or TxN1M0 or TxNxM1a or TxNxM1b (Only for cervical lymph nodes or celiac lymph nodes metastasis) based on the 6th UICC-TNM classification
•Eastern Cooperative Oncology Group(ECOG) performance status: 0-1
•Life expectancy ≥3 months
•Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

Exclusion Criteria

•Esophageal perforation or hematemesis
•Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
•Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L
•Allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection.
•Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
•Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
•Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
•Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
•According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.