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Clinical Trials/NCT03900871
NCT03900871
Unknown
Early Phase 1

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

Hebei Medical University Fourth Hospital1 site in 1 country600 target enrollmentApril 10, 2019

Overview

Phase
Early Phase 1
Intervention
Acetylsalicylic acid
Conditions
Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma
Sponsor
Hebei Medical University Fourth Hospital
Enrollment
600
Locations
1
Primary Endpoint
disease free survival
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 10, 2019
End Date
April 30, 2024
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hebei Medical University Fourth Hospital
Responsible Party
Sponsor

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.

Arms & Interventions

Experimental group

Intervention: Acetylsalicylic acid

Control group

Intervention: Acetylsalicylic acid

Outcomes

Primary Outcomes

disease free survival

Time Frame: 5 years

To observe the effect of aspirin on the disease free survival of patients with esophageal squamous cell carcinoma after operations

Study Sites (1)

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