Dendrobium Huoshanense Suppository in Rectal Cancer

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    168
  • sponsor
    Zhejiang Cancer Hospital
Updated on 22 October 2021

Summary

To evaluates the role of Dendrobium Huoshanense Suppository for radiation proctitis in locally advanced rectal cancer treated by capecitabine and irinotecan based neoadjuvant chemoradiation.

Details
Condition Locally Advanced Rectal Cancer
Treatment Dendrobium Huoshanense Suppository
Clinical Study IdentifierNCT05079438
SponsorZhejiang Cancer Hospital
Last Modified on22 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

pathological confirmed rectum adenocarcinoma
clinical stage T3-4 and/or N+
the distance from anal verge less than 10 cm
without distance metastases
performance status score: 0~1
without previous anti-cancer therapy
able to follow the protocol during the study period
sign the inform consen

Exclusion Criteria

Pregnant or breastfeeding women
Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance
Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months
Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
Subject blood routine and biochemical indicators do not meet the following criteria: hemoglobin 90g / L; absolute neutrophil count (ANC) 1.5 109 / L; Alanine transaminase (ALT), aspartate aminotransferase (AST) 2.5 times the upper limit of normal; alkaline phosphatase (ALP) 2.5 times the normal upper limit; serum total bilirubin <1.5 times the normal upper limit; serum creatinine <1 times the normal upper limit; serum albumin 30g / L
Anyone who is allergic to any research medication
DPD deficiency
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