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A Real-world Study Evaluating the Usage of Camrelizumab in Chinese Patients With Advanced Esophageal Cancer

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: NCT04616040
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Shen Lin, Peking University

Study Description
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Brief Summary:
The trial is a multi-center, open, observational registration study, which aims to evaluate the safety and efficacy of Camrelizumab (anti-PD-1 antibody) in the treatment of Chinese patients with advanced esophageal cancer in the real world.

Condition or disease Intervention/treatment
Esophageal Cancer Drug: Camrelizumab

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1030 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Non-interventional Registration Study Evaluating the Usage of Camrelizumab in the Treatment of Unresectable Locally Advanced/Recurrent or Metastatic Chinese Patients With Esophageal Cancer
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2023
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
unresectable locally advanced/recurrent or metastatic esophageal cancer Drug: Camrelizumab
The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events of Camrelizumab [ Time Frame: an expected average of 24 months ]
    especially Occurrence of ≥Grade 3 immune-related AEs


Secondary Outcome Measures :
  1. Adverse events of Camrelizumab [ Time Frame: an expected average of 24 months ]
    including other occasional or rare AEs

  2. Overall Survival [ Time Frame: an expected average of 24 months ]
    Duration from the date of initial treatment to the date of death due to any cause

  3. Progression-free Survival (PFS) [ Time Frame: an expected average of 24 months ]
    A duration from the date of initial treatment to radiographic disease progression or death of any cause

  4. Objective Response Rate (ORR) [ Time Frame: an expected average of 24 months ]
    Proportion of objective complete response and partial response patients


Other Outcome Measures:
  1. Correlations between biomarkers and clinical activity [ Time Frame: an expected average of 24 months ]
    tumor biopsies are collected before start of treatment, for assessing the relationship between different biomarkers (e.g. PD-L1 expression) with different camrelizumab-based regimens


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
unresectable locally advanced/recurrent or metastatic esophageal cancer
Criteria

Inclusion Criteria:

  1. Sign informed consent and voluntarily participate in this study.

  2. Unresectable locally advanced/recurring or distant metastatic esophageal cancer patients confirmed by histology or cytology (AJCC 8th edition);

    • Unresectable locally advanced patients who are unable or unable to receive radical treatment (including radical radio chemotherapy or radical radiotherapy, etc.) may be considered for inclusion;
    • Patients who progress or relapse after neoadjuvant or adjuvant therapy may also be considered for inclusion;
  3. Age ≥ 18 years old;
  4. The investigator determines that the patient can receive Camrelizumab as a single agent or combination therapy.

Exclusion Criteria:

  1. Evidence suggests that the patient is pregnant or breastfeeding;
  2. Other drug blinded clinical trials are currently underway;
  3. Other situations that are not suitable for inclusion in this study.
Contacts and Locations
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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): NCT04616040


Locations
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China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
Sponsors and Collaborators
Peking University
More Information
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Responsible Party: Shen Lin, Professor, Peking University
ClinicalTrials.gov Identifier: NCT04616040    
Other Study ID Numbers: LION-EC
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 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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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases