Status:
UNKNOWN
Probiotics Combined With Standard Chemotherapy Plus Targeted Therapy in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Zhejiang University
Cancer Hospital of The University of Chinese Academy of Sciences
Conditions:
Unresectable Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Bifico (also known as "bifidobacterium trifidum live powder") is a probiotic preparation that has been marketed and widely used in China. The number of live bacteria of lactobacillus acidophilus and b...
Detailed Description
Patients were randomized to either standard therapy (i.e., chemotherapy + targeted therapy) or standard therapy combined with Bifico. We will provide patients with first-line, second-line and third-li...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age ≥18 years and ≤75 years
- Histologically and radiologically confirmed colorectal adenocarcinomaImaging and/or pathology confirmed the presence of distal metastases
- Multidisciplinary team (MDT) identifies unresectable metastatic colorectal cancer (mCRC)
- RAS and BRAF genes are wild-type
- The patient had no previous treatment for mCRC, including chemotherapy, surgery, radiotherapy, hepatic artery chemoembolization (TACE) and targeted therapy
- Hematological function was normal (platelet \> 90×109/L; White blood cell \> 3×109/L; Neutrophil \> 1.5×109/L)
- Serum bilirubin ≤1.5 times the upper normal value (ULN), transaminase ≤5 times ULN
- No ascites, normal coagulation function, albumin ≥35g/L
- Child-push liver function was rated A
- Serum creatinine is below the upper normal limit (ULN) or the calculated creatinine clearance rate of \> 50ml/min (using Cockcroft-Gault formula)
- ECOG score 2-0
- Life expectancy \> 3 months
- Sign written informed consent
- Willing and able to receive follow-up until death or study completion or study termination
- Exclusion criteria:
- Patients who meet any of the following criteria will be excluded from the study:
- Recurrence of primary tumor
- Severe arterial embolism or ascites
- A tendency to bleed or clotting disorder
- Hypertensive crisis or hypertensive encephalopathy
- Severe uncontrolled systemic complications such as infection or diabetes
- Clinically serious cardiovascular diseases such as cerebrovascular accident (within 6 months before enrollment), myocardial infarction (within 6 months before enrollment), uncontrolled hypertension after appropriate drug treatment, unstable angina, congestive heart failure (nyha2-4), and arrhythmia requiring drug treatment
- History of central nervous system disease (e.g. primary brain tumor, epilepsy beyond the control of standard treatment, any brain metastasis or stroke)
- Other malignancies in the past 5 years (except basal cell carcinoma of skin and/or cervical carcinoma in situ after radical resection)
- Received any drug under study or treatment with the same type of drug in the last 28 days before the study
- Any residual toxicity from previous chemotherapy (except hair loss), such as peripheral neuropathy ≥NCI CTC v3.0 standard level 2
- Is allergic to any of the drugs in the study
- Pregnant and lactating women
- Inability or unwillingness to comply with research protocols
- The presence of any other disease, dysfunction due to metastatic lesions, or a suspected medical condition indicated a possible contraindication to the use of the study drug or a population at high risk for treatment-related complications
Exclusion
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 25 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT04131803
Start Date
October 1 2021
End Date
November 25 2025
Last Update
July 15 2021
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