Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

NCT03985046 | Completed Phase 2

• 1 other identifier: ESO-Shanghai14
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Local Control Rate

  up to 42 months

Secondary Outcomes (3)

• Adverse Events

  up to 42 months

• Progression-free Survival

  up to 42 months

• Overall Survival

  up to 42 months

Study Arms (1)

Sintilimab plus chemotherapy

EXPERIMENTAL

Drug: Sintilimab plus Chemotherapy

Interventions

Sintilimab plus Chemotherapy DRUG

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

Sintilimab plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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-L1.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Universtiy Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Ai D, Hao S, Shen W, Wu Q, Zhang S, Chen Y, Liu Q, Deng J, Zhu H, Chen K, Mo M, Gu D, Liu Y, Zhang Z, Zhou G, Hu J, Zhang Z, Ye J, Zhao K. Induction sintilimab and chemotherapy followed by concurrent chemoradiotherapy for locally advanced esophageal cancer: a proof-of-concept, single-arm, multicenter, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102471. doi: 10.1016/j.eclinm.2024.102471. eCollection 2024 Mar.

  PMID: 38356729 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

sintilimab; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: October 10, 2019
• Primary Completion: May 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CN (1)