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

NCT04131803 | Unknown DMC

• 1 other identifier: DIFFERENCE
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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 bifidobacterium per gram should not be less than 1.0×107CFU. At present, it is mainly used for diarrhea and abdominal distension caused by intestinal flora imbalance. It can also be used for treating mild to moderate acute diarrhea and chronic diarrhea. Lactobacillus acidophilus and bifidobacteria have been fully proved in basic studies to improve gut microbiological environment and inhibit colorectal cancer. A recent paper published by Nature Biomedical Engineering reported that chemotherapy can effectively enhance the efficacy of colon cancer by regulating intestinal flora. Based on the above evidence, we propose that the current standard chemotherapy plus targeted therapy regimen combined with Bifico can exert a more powerful synergistic anticancer effect. To sum up, this study put forward innovative joint regulating intestinal flora environment with standard chemotherapy and target therapy of new concept and mode, to assess Bifico combined with standard chemotherapy plus targeted therapy compared to standard chemotherapy plus targeted therapy for efficacy and safety of metastatic colorectal cancer, combined with the intestinal flora, probiotics patient blood DNA analysis, etc. New technology, explore flora index correlation with the prognosis of patients' immune system function, and its potential as a predictive marker. It is worth noting that this study will closely combine the current most advanced intestinal flora 16S microbial polymorphism detection and single-cell sequencing technology, so as to truly achieve accurate and individualized treatment, evaluation and prognosis prediction.

Conditions

Unresectable Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

  1 year

Study Arms (2)

Bifico combined with chemotherapy plus targeted therapy

EXPERIMENTAL

Bifico combined with chemotherapy plus targeted therapy

Drug: Bifico combined with chemotherapy plus targeted therapy

chemotherapy plus targeted therapy

EXPERIMENTAL

chemotherapy plus targeted therapy

Drug: chemotherapy plus targeted therapy

Interventions

Bifico combined with chemotherapy plus targeted therapy DRUG

Bifico combined with chemotherapy plus targeted therapy

Also known as: Bifico+chemotherapy+targeted therapy

Bifico combined with chemotherapy plus targeted therapy

chemotherapy plus targeted therapy DRUG

chemotherapy plus targeted therapy

Also known as: chemotherapy+targeted therapy

chemotherapy plus targeted therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Zhejiang University: collaborator
• Cancer Hospital of The University of Chinese Academy of Sciences: collaborator
• Hebei Medical University Fourth Hospital: collaborator

MeSH Terms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 18, 2019
• Study Start: October 1, 2021
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2025
• Last Updated: July 15, 2021

Record last verified: 2020-10