Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
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.
| Status | Not yet recruiting |
| Enrollment | 600 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | April 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Junfeng Liu | Shijiazhuang | Hebei |
| Lead Sponsor | Collaborator |
|---|---|
| Hebei Medical University Fourth Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |