Chemotherapy w/wo WeiLeShu in Metastatic Colorectal Cancer

Zhejiang University

Status and phase: Completed; Phase 2

Conditions: Microbial Colonization; Colorectal Cancer

Treatments: Drug: Weileshu; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04021589

Microbio-WLS001

Details and patient eligibility

About

A total of 50 patients with metastatic colorectal cancer will be enrolled in the study. The patients were randomly divided into the WLS-intervention group and the control group. The two groups of patients were given the most appropriate medication according to the specific conditions of the disease. Patients in the intervention group received additional oral administration of Weileshu, a probiotics product (Tongchuang Biotechnology).

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years of age, of any race or sex who are eligible to sign written consent and have undergone prior resection of histological evidence of colorectal cancer
• Hematologic function: ANC ≥ 1.5 x 10 /L, platelets ≥ 75 x 10 /L, and hemoglobin > 9 g/dL Adequate liver function as measured by: total bilirubin ≤ 2.0 mg/dl, AST and ALT ≤ 5 ULN, albumin ≥ 2.5 g/dl Adequate renal function as measured by: creatinine ≤ 2.9 mg/dl, > 50 ml/min calculated by the C-G equation Non-pregnant women of childbearing potential and fertile men are required to use effective contraception (negative pregnancy test for women of child-bearing age) ECOG status ≤ 1 at screening

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

WLS-intervention group

Experimental group

Description:

chemotherapy + WLS

Treatment:

Drug: Chemotherapy

Drug: Weileshu

the control group

Active Comparator group

Description:

chemotherapy

Treatment:

Drug: Chemotherapy