NCT04394598

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 .

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	Dendrobium Huoshanense Granules	3g tid per day for 5weeks
RADIATION	Pelvic Radiation	50Gy/25Fx
DRUG	Capecitabine	625mg/m2 bid Monday-Friday per week
DRUG	Irinotecan	80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)
OTHER	Placebo	3g tid per day for 5weeks

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2020-05-19
• Last updated: 2020-05-19

Locations

1 site across 1 country: China