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Irinotecan

Capecitabine

Dendrobium huoshanense Suppository: 1.7g rectal administration per day for 5 weeks

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2 (UGT1A1\*28 and \*6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1\*28 and \*6 ：7/7+GG or 6/6+AA or 6/7+GA）.

Placebo: 1.7g rectal administration per day for 5 weeks

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 and \*6: 6/6+GG) or 65mg/m2 (UGT1A1\*28 and \*6 ：6/7+GG or 6/6+GA) or 50mg/m2 （UGT1A1\*28 and \*6 ：7/7+GG or 6/6+AA or 6/7+GA）.

1.7g rectal administration per day for 5 weeks

Dendrobium Huoshanense Suppository

Ji Zhu, MD

JI Zhu, MD

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

Dendrobium Huoshanense Suppository in Rectal Cancer

A Multicenter Randomized Controlled Stage III Clinical Study of Dendrobium Huoshanense Suppository in Locally Advanced Rectal Cancer Patients Treated by Neoadjuvant Chemoradiotherapy

Zhejiang Cancer Hospital

Professor

Antimetabolites

Topoisomerase I Inhibitors

Enzyme Inhibitors

Dendrobium Huoshanense Granules: 3g tid per day for 5weeks

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Placebo: 3g tid per day for 5weeks

Concurrent Chemoradiotherapy:

Radiation: 50Gy/25Fx; Capecitabine: 625mg/m2 bid Monday-Friday per week; Irinotecan: 80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Chemotherapy in Interval Between CRT and Surgery:

Capecitabine: 1000mg/m2 bid d1-14; Irinotecan: 200mg/m2 d1

Surgery:

Scheduled 6-8 weeks after the completion of CRT Adjuvant Chemotherapy: depends on patients pathological review.

Dendrobium Huoshanense Granules

Pelvic Radiation

80mg/m2 (UGT1A1\*28 6/6) or 65mg/m2 (UGT1A1\*28 6/7)

Placebo

Zhen Zhang, MD

Zhu Ji, MD

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 .

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

Fudan University

Clinical Professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dendrobium Huoshanense Suppository in Rectal Cancer	NCT05079438	Locally Advance...	Dendrobium Huos...	18 Years - 75 Years	Zhejiang Cancer Hospital
Dendrobium Huoshanense Suppository in Rectal Cancer	NCT05079438	Locally Advance...	Dendrobium Huos...	18 Years - 75 Years	Zhejiang Cancer Hospital
Dendrobium Huoshanense Suppository in Rectal Cancer	NCT05079438	Locally Advance...	Dendrobium Huos...	18 Years - 75 Years	Zhejiang Cancer Hospital
A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer	NCT04394598	Locally Advance...	Dendrobium Huos... Pelvic Radiatio... Capecitabine Irinotecan Placebo	18 Years - 70 Years	Fudan University
A Study of Chinese Herbal Compound Dendrobium Huoshanense Granules in NCRT for Patients With Locally Advanced Rectal Cancer	NCT04394598	Locally Advance...	Dendrobium Huos... Pelvic Radiatio... Capecitabine Irinotecan Placebo	18 Years - 70 Years	Fudan University

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