Dendrobium Huoshanense Suppository in Rectal Cancer

University of Chinese Academy Sciences

Status and phase: Enrolling; Phase 3

Conditions: Locally Advanced Rectal Cancer

Treatments: Drug: Dendrobium Huoshanense Suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT05079438

CARTOnG-2103

Details and patient eligibility

About

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

Enrollment: 168 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

CRT with Dendrobium huoshanense Suppository

Experimental group

Description:

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）.

Treatment:

Drug: Dendrobium Huoshanense Suppository

CRT with Placebo

No Intervention group

Description:

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）.