Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

Fudan University

Status and phase: Completed; Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: Sintilimab plus Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03985046

ESO-Shanghai14

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Written informed consent

2. Aged 18-75 years

3. Histologically confirmed esophageal squamous cell carcinoma

4. 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

5. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. 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

1. Esophageal perforation or hematemesis
2. 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).
3. Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
4. Allergic to macromolecular protein preparations, or to any of the ingredients in sintilimab for injection.
5. 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.
6. 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.
7. Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
8. Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
9. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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75 participants in 1 patient group

Sintilimab plus chemotherapy

Experimental group

Treatment:

Drug: Sintilimab plus Chemotherapy