A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer

  • End date
    Dec 1, 2022
  • participants needed
  • sponsor
    Fudan University
Updated on 25 January 2021


The study evaluates the addition of Chinese Herbal Compound Dendrobium Huoshanense Granules to capecitabine and irinotecan in neoadjuvant chemoradiation(CRT) in locally advanced rectal cancer. Half of participants will receive CRT with Dendrobium Huoshanense Granules, while the others will receive CRT with placebo. We will evaluate whether Dendrobium Huoshanense Granules can enhance the immune function and alleviate symptoms caused by the tumor and CRT .

Condition Locally Advanced Rectal Cancer
Treatment Capecitabine, Placebo, Irinotecan, Pelvic Radiation, Dendrobium Huoshanense Granules
Clinical Study IdentifierNCT04394598
SponsorFudan University
Last Modified on25 January 2021


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
UGT1A128 6/6 or 6/7
without previous anti-cancer therapy
able to follow the protocol during the study period
sign the inform consent

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
UGT1A128 7/7
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