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The Efficacy of Immunodetection Point Inhibitors for Advanced Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT04074447
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Ruihua Xu, Sun Yat-sen University

Brief Summary:
Esophageal cancer is one of the most common malignancies of the digestive system. Esophageal squamous cell carcinoma is the main type of esophageal cancer, accounting for more than 90% of esophageal cancer in China. The 5-year survival rate is about 15%~25%. Many patients with esophageal cancer are initially diagnosed as advanced, and many patients with early initial diagnosis will still relapse and metastasis after radical treatment. Currently, chemotherapy plays a central role in palliative care, but its objective remission rate is only 20-40%, and the median survival is about 8-10 months. However, most of the current phase III studies on targeted drugs for esophageal squamous cell carcinoma have failed, and the treatment of esophageal squamous cell carcinoma has entered the bottleneck stage. Therefore, it is urgent to explore a treatment method that can significantly improve the prognosis of patients with esophageal cancer. In recent years, with the development of biological immunotherapy, immunocheckpoint inhibitors, including pd-1 inhibitors, pd-l1 inhibitors and ctla-4 inhibitors, have achieved significant curative effect and made breakthroughs in the treatment of multiple solid tumors including melanoma, non-small cell lung cancer and kidney cancer. These immunocheckpoint inhibitors have also been tried for esophageal cancer, with initial success in immunotherapy for esophageal cancer. In this observational study, all patients with esophageal cancer who used immunocheckpoint inhibitors in clinical practice were included, without limitation on the number of treatment lines or combinations of different chemotherapy. Through follow-up observation, the purpose of this study was to analyze the efficacy of immunocheckpoint inhibitors for esophageal cancer in the real world, and to explore the differences in the efficacy of immunocheckpoint inhibitors in different stages of treatment, as well as the efficacy of different chemotherapy combinations, so as to provide clinical evidence for the use of immunotherapy for advanced esophageal cancer.

Condition or disease
Esophageal Cancer

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Real World Study on the Efficacy of Immunodetection Point Inhibitors for Advanced Esophageal Cancer
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. The proportion of ctDNA content decreased in patients with good therapeutic effect [ Time Frame: through study completion, an average of 2 years ]
    The proportion of patients with good therapeutic effect whose serum ctDNA content decreased (in any follow-up)


Biospecimen Retention:   Samples With DNA
blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
A total of 80 patients with advanced esophageal cancer were enrolled. Patients need to be treated with second - or third-line chemotherapy combined with immunocheckpoint inhibitors. 10ml of edta-anticoagulant blood was collected before the first treatment of the enrolled patients, and the blood samples were gently reversed in the anticoagulant tube for several times to fully anticoagulate. The upper plasma and the lower blood cells were centrifuged at 1800g for 10 min within 4 hours, respectively, and stored at -80 ℃ for later use and provide 5-10 tissue white sheets.
Criteria

Inclusion Criteria:

  1. age above 18, male or female.
  2. patients with esophageal cancer confirmed by pathology through tumor biopsy or puncture tissue.
  3. the patient was assessed as untreatable by surgery.
  4. patients received second-line or third-line chemotherapy and were treated with immunodetector point inhibitors.
  5. the patient had complete preliminary pathological information, tumor site, pathological type and other information.
  6. the patient must have adequate tumor tissue or 5-10 FFPE white tablets to provide; After treatment, patients were returned to the hospital for re-examination every 3 treatment cycles, and plasma and peripheral blood samples could be obtained during the whole process.
  7. other indicators of the patients met the general clinical trial enrollment conditions.
  8. subjects read and fully understand the instructions to patients, and sign the informed consent.

Exclusion Criteria:

  1. blood samples cannot be obtained before treatment.
  2. the patient has clear infection status.
  3. the patient has other serious diseases besides esophageal cancer.

(5) current patients with alcoholism or drug abuse. (6) pregnant female patients. (7) the patient has a clear history of neurological or mental disorders.


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): NCT04074447


Contacts
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Contact: Dongsheng Zhang, MD.,PhD. 86-2087343804 Zhangdsh@sysucc.org.cn
Contact: Zhida Lv, BS. 86-2087343795 lvzd@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rui-Hua Xu, MD, PhD    +862087342635    lvzd@sysucc.org.cn   
Principal Investigator: Rui-hua Xu, MD, PhD         
Sub-Investigator: Dongsheng Zhang, MD, PhD         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Rui-hua Xu Sun Yat-sen University
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Responsible Party: Ruihua Xu, president, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04074447    
Other Study ID Numbers: ctDNA-1
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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