Probiotics Combined With Standard Chemotherapy Plus Targeted Therapy in Patients With Metastatic Colorectal Cancer

Launched by SECOND AFFILIATED HOSPITAL, SCHOOL OF MEDICINE, ZHEJIANG UNIVERSITY · Oct 16, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether a probiotic called Bifico can enhance the effectiveness of standard chemotherapy and targeted therapy for patients with metastatic colorectal cancer, which is cancer that has spread and cannot be surgically removed. Bifico contains live bacteria that may help improve gut health, and previous studies suggest that it could boost the benefits of chemotherapy. The goal of the study is to see if combining Bifico with these treatments can improve patient outcomes and potentially provide new insights into how gut health relates to cancer treatment.

To be eligible for the trial, participants must be between 18 and 75 years old, have a confirmed diagnosis of metastatic colorectal cancer, and have not received any previous treatments for this condition. Additionally, they need to have certain blood counts and liver function levels within the normal range. Participants will be monitored closely throughout the trial, and their gut health and immune function will be analyzed to understand better how these factors might impact their treatment response. This research aims to personalize cancer treatment and improve the understanding of how probiotics can play a role in cancer care.

Gender

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Eligibility criteria

• Inclusion criteria:
• • 1. Age ≥18 years and ≤75 years
• • 2. Histologically and radiologically confirmed colorectal adenocarcinomaImaging and/or pathology confirmed the presence of distal metastases
• • 3. Multidisciplinary team (MDT) identifies unresectable metastatic colorectal cancer (mCRC)
• • 4. RAS and BRAF genes are wild-type
• • 5. The patient had no previous treatment for mCRC, including chemotherapy, surgery, radiotherapy, hepatic artery chemoembolization (TACE) and targeted therapy
• • 6. Hematological function was normal (platelet \> 90×109/L; White blood cell \> 3×109/L; Neutrophil \> 1.5×109/L)
• • 7. Serum bilirubin ≤1.5 times the upper normal value (ULN), transaminase ≤5 times ULN
• • 8. No ascites, normal coagulation function, albumin ≥35g/L
• • 9. Child-push liver function was rated A
• • 10. Serum creatinine is below the upper normal limit (ULN) or the calculated creatinine clearance rate of \> 50ml/min (using Cockcroft-Gault formula)
• • 11. ECOG score 2-0
• • 12. Life expectancy \> 3 months
• • 13. Sign written informed consent
• • 14. 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:
• • 1. Recurrence of primary tumor
• • 2. Severe arterial embolism or ascites
• • 3. A tendency to bleed or clotting disorder
• • 4. Hypertensive crisis or hypertensive encephalopathy
• • 5. Severe uncontrolled systemic complications such as infection or diabetes
• • 6. 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
• • 7. History of central nervous system disease (e.g. primary brain tumor, epilepsy beyond the control of standard treatment, any brain metastasis or stroke)
• • 8. Other malignancies in the past 5 years (except basal cell carcinoma of skin and/or cervical carcinoma in situ after radical resection)
• • 9. Received any drug under study or treatment with the same type of drug in the last 28 days before the study
• • 10. Any residual toxicity from previous chemotherapy (except hair loss), such as peripheral neuropathy ≥NCI CTC v3.0 standard level 2
• • 11. Is allergic to any of the drugs in the study
• • 12. Pregnant and lactating women
• • 13. Inability or unwillingness to comply with research protocols
• • 14. 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