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Camrelizumab vs Placebo as Maintenance Therapy After 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. Identifier: NCT03985046
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Jiangsu HengRui Medicine Co., Ltd.
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 camrelizumab vs placebo as maintenance therapy after definitive concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: Camrelizumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double-blind Phase II Study of Camrelizumab vs Placebo as Maintenance Therapy After Definitive Concurrent Chemoradiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
Estimated Study Start Date : July 1, 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: Camrelizumab Drug: Camrelizumab
Camrelizumab will be administered intravenously, a fixed dose of 200 mg. Each infusion lasts for 30 min, once every 2 weeks. The cumulative longest medication period is 12 months.

Placebo Comparator: Placebo Drug: Placebo
Placebo will be administered intravenously, a fixed dose of 200 mg. Each infusion lasts for 30 min, once every 2 weeks. The cumulative longest medication period is 12 months.

Primary Outcome Measures :
  1. progression-free survival [ Time Frame: up to 42 months ]
  2. overall survival [ Time Frame: up to 42 months ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: up to 42 months ]

Information from the National Library of Medicine

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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

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. Received definitive radiation therapy for esophageal cancer (DT: 50.0Gy-68.4Gy) and concurrent chemotherapy (at least 2 monthly cycles or 4 weekly cycles)
  6. Randomization within 14 days of last radiotherapy
  7. No progression observed before randomization
  8. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1
  9. Life expectancy ≥3 months
  10. 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. Adverse events greater than grade 2 caused by the treatment prior to randomization have not been recovered (ie, grade 1 or baseline), and adverse events (such as neurotoxicity) that are difficult to recover quickly can be enrolled according to the investigator.
  4. According to the investigator, non-infectious pneumonia caused by previous radiotherapy and chemotherapy still exists.
  5. Previously received or receiving other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
  6. Allergic to macromolecular protein preparations, or to any of the ingredients in camrelizumab for injection.
  7. 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.
  8. 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.
  9. Active infection or unexplained fever >38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
  10. Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
  11. 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.

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Responsible Party: Kuai Le Zhao, MD, Professor, Fudan University Identifier: NCT03985046     History of Changes
Other Study ID Numbers: ESO-Shanghai14
ESC-MT-IIT-SHR1210-CRT-FDZ ( Other Identifier: Jiangsu HengRui Medicine Co., Ltd. )
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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