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NCT03900871

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

Status unknown EARLY_PHASE1 Last updated 3 April 2019
What this trial tests

EARLY_PHASE1 trial testing Acetylsalicylic acid in Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma in 600 participants. Status unknown.

Timeline
10 April 2019
Primary endpoint
30 April 2020
30 April 2024

Quick facts

Lead sponsorHebei Medical University Fourth Hospital
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment600
Start date10 April 2019
Primary completion30 April 2020
Estimated completion30 April 2024
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Hebei Medical University Fourth Hospital

Who can join

Adults 18 to 70, any sex, with Aspirin as an Adjuvant Therapy, to Observe Its Effect on the Disease Free Survival Rate of Patients With Esophageal Squamous Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
    Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006

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