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UNKNOWNPHASE2

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

A Phase II Randomized Study of the Protection Effect of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer

NCT04394598•Fudan University

View on ClinicalTrials.gov

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 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 .

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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
•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 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
•UGT1A1\*28 7/7

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2020

Primary Completion Date

June 1, 2022

Completion Date

December 1, 2022

Last Updated

May 19, 2020

Enrollment

210

ESTIMATED participants

Conditions

Locally Advanced Rectal Cancer

Interventions

Dendrobium Huoshanense Granules

DRUG

Pelvic Radiation

RADIATION

Capecitabine

DRUG

Irinotecan

DRUG

Placebo

OTHER

Contacts

Ji Zhu, MD

CONTACT

+86-2164175590 leo.zhu@126.com

Zhen Zhang, MD

CONTACT

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

NCT05412082

Locally Advanced Rectal Cancer

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RECRUITINGPHASE2

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

NCT06204094

Locally Advanced Rectal Cancer

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RECRUITINGPHASE2

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

SMART TNT for the Conservative Management of Locally Advanced Rectal Cancer

Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence

A Pospective, Single-arm, Multicenter Clinical Trial Evaluating Preoperative Neoadjuvant mFOLFOX6 Chemotherapy in Combination With PD1 Monoclonal Antibody in MSS/pMMR Locally Advanced Rectal Cancer

Intraoperative Electron Radiotherapy in Rectal Cancer - A Feasibility Trial

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer