Dendrobium Huoshanense Suppository in Rectal Cancer

Phase 3

Recruiting

• Conditions: Locally Advanced Rectal Cancer
• Interventions: Drug: Dendrobium Huoshanense Suppository

• Registration Number: NCT05079438
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-07
• Status Verified: 2021-10
• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Primary Completion: 2023-07-30
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

1. pathological confirmed rectum adenocarcinoma
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 10 cm
4. without distance metastases
5. performance status score: 0~1
6. without previous anti-cancer therapy
7. able to follow the protocol during the study period
8. sign the inform consen

Exclusion Criteria

1. Pregnant or breastfeeding women
2. Those with other history of malignant disease in the past 5 years, except for cured skin cancer and cervical carcinoma in situ
3. 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.
4. 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
5. Organ transplantation requires immunosuppressive therapy Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
6. 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
7. Anyone who is allergic to any research medication
8. DPD deficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT with Dendrobium huoshanense Suppository	Dendrobium Huoshanense Suppository	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）.

Primary Outcome Measures

Name	Time	Method
≥Grade 2 proctitis	During chemoradiotherapy

Trial Locations

Locations (1)

Ji Zhu; 🇨🇳 Hangzhou, Zhejiang, China