Status:
UNKNOWN
A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer
Lead Sponsor:
Fudan University
Conditions:
Locally Advanced Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- UGT1A1\*28 6/6 or 6/7
- without previous anti-cancer therapy
- able to follow the protocol during the study period
- sign the inform consent
Exclusion
- 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
- UGT1A1\*28 7/7
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04394598
Start Date
March 1 2020
End Date
December 1 2022
Last Update
May 19 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200023