Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985046
• Other study ID #: ESO-Shanghai14
• Status: Completed
• Phase: Phase 2
• Start date: October 10, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

7. 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Sintilimab plus Chemotherapy
Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=5. Once every 3 weeks.

Locations

Country	Name	City	State
China	Fudan Universtiy Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Control Rate		up to 42 months
Secondary	Adverse Events		up to 42 months
Secondary	Progression-free Survival		up to 42 months
Secondary	Overall Survival		up to 42 months