Clinical Research on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma

Prospective, Randomized, Blind, Parallel Controlled Clinical Research Programme on the Effect of Aspirin on the Disease Free Survival Rate of Esophageal Carcinoma

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Acetylsalicylic acid

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Junfeng Liu; Phone Number: 13931152296; Email: liujf@hbmu.edu
• Study Contact Backup: Name: Jiang Jiang; Phone Number: 15531187025; Email: 283706939@qq.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Junfeng Liu
      • Contact: Junfeng Liu, Professor; Phone Number: 13931152296; Email: 13931152296@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Drug: Acetylsalicylic acid; 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.
Placebo Comparator: Control group	Drug: Acetylsalicylic acid; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease free survival	To observe the effect of aspirin on the disease free survival of patients with esophageal squamous cell carcinoma after operations	5 years

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital
• Investigators: Study Chair: Junfeng Liu, Hebei Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 10, 2019
• Primary Completion (Anticipated): April 30, 2020
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Carcinoma; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 2018051702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No