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A Real-World Study of Immune Checkpoint Inhibitors and Chemotherapy for 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: NCT04822103
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
Shantou Central Hospital
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

Brief Summary:
The role of neoadjuvant chemotherapy as standard therapy is well-established for locally advanced esophageal cancer. Immunotherapeutic agents such as Immune checkpoint inhibitors has been shown to improve objective response rate in solid tumors. However, there is a paucity of data regarding the efficacy and safety of neoadjuvant immunotherapy plus chemotherapy in esophageal cancer patients in real-world practice. This study set out to investigate whether the combination of neoadjuvant chemotherapy and immune checkpoint inhibitors is beneficial to improve the objective response rate as well as the pathological complete response rate in a real-world scenario.

Condition or disease
Esophageal Cancer

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Real-World Study Evaluating the Efficacy and Safety of Immune Checkpoint Inhibitors and Chemotherapy for Advanced Esophageal Cancer
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 weeks ]
    Objective Response Rate


Secondary Outcome Measures :
  1. Pathologic complete response rate (pCR) [ Time Frame: Three to five working days after surgery ]
    The rate of pathologic complete response rate after the combined treatment of chemotherapy and immunotherapy following surgery

  2. R0 resection rate [ Time Frame: Three to five working days after surgery ]
    The R0 resection rate of esophagectomy



Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients diagnosed as potentially resectable esophageal squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function and no distant metastasis are included in the study
Criteria

Inclusion Criteria:

  • Pathologically diagnosed as esophageal squamous cell carcinoma
  • KPS≥80
  • Adequate organ function
  • No distant metastasis
  • The diseases could be resected or potentially resectable assessed by a thoracic oncologist

Exclusion Criteria:

  • incomplete medical record which affects statistical analysis
  • have participated in previous interventional clinical trials
  • other situations evaluated by investigators not meet the enrollment

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): NCT04822103


Contacts
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Contact: Guibin Qiao, MD 13602749153 guibinqiao@126.com

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Guibin Qiao, MD    13602749153    guibinqiao@126.com   
Contact: Shujie Huang, MD    13592844883    shujie_huang@163.com   
Shantou Central Hospital Recruiting
Shantou, Guangdong, China, 515031
Contact: Junhui Fu, MD    13556301818    18029500042@163.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Shantou Central Hospital
Investigators
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Principal Investigator: Guibin Qiao, MD Guangdong Provincial People's Hospital
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04822103    
Other Study ID Numbers: RICE-retro
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangdong Provincial People's Hospital:
esophageal cancer
real-world study
immunotherapy
chemotherapy
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