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Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03985046
Recruitment Status : Recruiting
First Posted : June 13, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Kuai Le Zhao, MD, Fudan University

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Sintilimab plus Chemotherapy Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Sintilimab Plus Chemotherapy Followed by Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sintilimab plus chemotherapy Drug: Sintilimab plus Chemotherapy
Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=6. Once every 3 weeks.




Primary Outcome Measures :
  1. Local Control Rate [ Time Frame: up to 42 months ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 42 months ]
  2. Progression-free Survival [ Time Frame: up to 42 months ]
  3. Overall Survival [ Time Frame: up to 42 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985046


Contacts
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Contact: Kuaile Zhao, MD 86-21-64175590 kuaile_z@sina.com

Locations
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China, Shanghai
Fudan Universtiy Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Kuaile Zhao, MD.    +8618017312534    kuaile_z@sina.com   
Sponsors and Collaborators
Fudan University
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Responsible Party: Kuai Le Zhao, MD, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT03985046    
Other Study ID Numbers: ESO-Shanghai14
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal 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