Back to resultsClinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma
Primary Purpose
Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma
Status
Not yet recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Hospitalized patients with malignant tumors after radical operation of esophageal squamous cell carcinoma without merging other parts; Pathological results are shown as all staging; Immunohistochemical staining showed positive COX-2 expression; Aspirin or other non-steroidal anti-inflammatory drugs have not been taken in the past; No abnormalities found in coagulation function; Between the ages of 18-70 and five, gender is not limited; Patient KPS≥90, expected survival period of more than 6 months; Patient Signs Informed Consent statement; Pregnant women with fertility must be negative in pregnancy trials.
Exclusion Criteria:
- Severe coagulation dysfunction; Severe liver, kidney and cardiac dysfunction; The lesion failed to completely remove; Active digestive tract Ulcers; Reflux esophageal disease; Allergies to aspirin or other drugs containing salicylic acid; History of asthma caused by salicylic acid salts or salicylate containing substances and non-steroidal anti-inflammatory drugs; COX-2 expression of immune tissue chemical staining weak or not expressed; Wide transfer of the whole body; Ever taken aspirin or other non-steroidal anti-inflammatory drugs; Pregnant and lactating women.
Sites / Locations
- Junfeng Liu
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
Outcomes
Primary Outcome Measures
disease free survival
To observe the effect of aspirin on the disease free survival of patients with esophageal squamous cell carcinoma after operations
Secondary Outcome Measures
Full Information
NCT ID
NCT03900871
First Posted
April 1, 2019
Last Updated
April 1, 2019
Sponsor
Hebei Medical University Fourth Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03900871
Brief Title
Clinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma
Official Title
Prospective, Randomized, Blind, Parallel Controlled Clinical Research Programme on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 10, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Fourth Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Esophageal cancers are the seventh most common cancer in the world and one of the most common causes of cancer deaths. In some parts of China, the incidence of SCC is among the highest in the world. Despite surgery and adjuvant radiotherapy, the prognosis for SCC patients was disappointing. There is therefore an urgent need for new prevention and treatment strategies.
Epidemiological investigations have found that about 25% of human tumors are associated with chronic inflammation caused by a variety of causes, and chronic inflammation activates nuclear transcription factors (nuclear Factor,NF), induces gene and epigenetic changes such as DNA methylation, tumor suppressor gene point mutations, and post-translational modification, and participates in the process of tumorigenesis. It has been noted that the long-term regularity of the use of non-steroidal anti-inflammatory drugs aspirin can reduce the incidence and mortality of a variety of tumors, including esophageal cancer.
Aspirin is the earliest, most extensive and common antipyretic analgesics and anti-rheumatism drugs used to play an anti-inflammatory role by inhibiting the synthesis of PGs. COX-2 is a key enzyme in the synthesis of PGs, so it is speculated that the anti-tumor effect of aspirin inhibits the PGs of COX and its inhibition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Intervention Description
Aspirin (aspirin), also known as acetylsalicylic acid (acetylsalicylic acid), is a salicylic acid drug commonly used as a painkiller, antipyretic and anti-inflammatory drug. There is growing evidence that aspirin has a preventive effect on certain cancers, especially gastrointestinal cancers, and that taking aspirin every day can reduce the risk of colon cancer, and in vitro experiments have also shown that aspirin inhibits the growth of a variety of cancer cells and induces apoptosis.
Primary Outcome Measure Information:
Title
disease free survival
Description
To observe the effect of aspirin on the disease free survival of patients with esophageal squamous cell carcinoma after operations
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hospitalized patients with malignant tumors after radical operation of esophageal squamous cell carcinoma without merging other parts; Pathological results are shown as all staging; Immunohistochemical staining showed positive COX-2 expression; Aspirin or other non-steroidal anti-inflammatory drugs have not been taken in the past; No abnormalities found in coagulation function; Between the ages of 18-70 and five, gender is not limited; Patient KPS≥90, expected survival period of more than 6 months; Patient Signs Informed Consent statement; Pregnant women with fertility must be negative in pregnancy trials.
Exclusion Criteria:
Severe coagulation dysfunction; Severe liver, kidney and cardiac dysfunction; The lesion failed to completely remove; Active digestive tract Ulcers; Reflux esophageal disease; Allergies to aspirin or other drugs containing salicylic acid; History of asthma caused by salicylic acid salts or salicylate containing substances and non-steroidal anti-inflammatory drugs; COX-2 expression of immune tissue chemical staining weak or not expressed; Wide transfer of the whole body; Ever taken aspirin or other non-steroidal anti-inflammatory drugs; Pregnant and lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junfeng Liu
Phone
13931152296
Email
liujf@hbmu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Jiang
Phone
15531187025
Email
283706939@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junfeng Liu
Organizational Affiliation
Hebei Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Junfeng Liu
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junfeng Liu, Professor
Phone
13931152296
Email
13931152296@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma
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