Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

The intervention group patients receive platinum-based doublet chemotherapy plus BIFICO (Dose: 420mg, 3 times a day, p.o)

The control group patients receive platinum-based doublet chemotherapy plus Placebo (Dose: 420mg, 3 times a day, p.o)

Patients in BIFICO group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Bifico.

bifico

Patients in control group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Placebo.

placebo

Lihong Fan, Doctor

Based on the theory of intestinal lung axis, the effect of new therapy on patients with advanced NSCLC was observed by adjusting the intestinal micro-ecology and combining existing platinum-based doublet chemotherapy.

OBJECTIVES:

Primary outcomes To compare progression free survival (PFS) and objective response rate (ORR) in patients with stage IIIB or IV non-small cell lung cancer receiving Bifico versus placebo plus platinum-based doublet chemotherapy for first-line treatment.

Secondary outcomes To compare overall survival (OS) between the two arms； To evaluate the nature, severity, and frequency of toxicities between arms； To correlate the blood markers and fecal microbiome (at diagnosis) with outcomes and response.

OUTLINE:

This is a randomized, double-blind, placebo-controlled clinical trial. Patients are stratified according to center, performance status (0 or 1), tobacco use (never vs past or present), weight loss (\< 5% vs ≥ 5% or unknown). Patients are randomized to 1 of 2 treatment arms.

BIFICO Group: Patients receive Bifico (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Placebo Group: Patients receive placebo (420mg, 3 times a day, p.o) plus platinum-based doublet chemotherapy. Chemotherapy repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Blood, tissue and fecal samples are collected and examined for biomarkers, gene mutations and fecal microbiome, and may be banked for future studies.

A placebo-controlled double-blind randomized study

Probiotics Combined With Chemotherapy for Patients With Advanced NSCLC

A Prospective Multicenter Double-blind Randomized Clinical Trial of Probiotics Combined With Chemotherapy in the Treatment of Patients With Advanced Non-small Cell Lung Cancer

Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported. Objective response rate is the sum of CR + PR divided by the total number of patients in each group.

progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee

Randomization to Date of Death from Any Cause.

Incidence of Toxicities Measured by NCI CTCAE Version 4.0

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai Chest Hospital

Shanghai 10th People's Hospital

Associate senior doctor

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

All Drugs and Chemicals

Other Dietary Supplements

Liver Extracts

Acidophilus

Bifidobacterium

Continued administration during perioperative period

Live combined Bifidobacterium, Lactobacillus and Enterococcus Capsules

BIFICO

Bixiang Zhang

Jingjing Yu

On the basis of previous studies, this study intends to explore the effect of BIFICO on liver function recovery of patients with hepatocellular carcinoma (HCC) after surgery, so as to provide a new method for accelerating liver function recovery of HCC patients during perioperative period.

This project is an open, randomized, blank-controlled clinical study. Liver resection patients were randomly divided into two groups, one group received continuous administration of BIFICO during perioperative period, and the dosage was controlled according to the instructions. The other group was a blank control. Stool samples were collected at three time points (before medication, before and after surgery) in two groups. Statistical analysis was performed to compare the differences of postoperative liver function and preoperative and postoperative gut microbiota between the two groups.

Through this study, the investigators aimed to verify the beneficial changes of intestinal microflora in HCC patients with BIFICO during perioperative period .

Hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the digestive system, with a high incidence in the world and the third highest mortality rate among all malignant tumors in China. In recent years, studies have found that intestinal microflora disorder can also promote the occurrence and development of HCC through various ways, such as endotoxemia, metabolic disorders, and increased risk of exposure to HBV and aflatoxin. In the treatment of HCC, in addition to the traditional comprehensive treatment based on surgical resection, the treatment for intestinal microflora disorder also plays a unique role in improving prognosis and alleviating complications.

At present, increasing the number of beneficial bacteria through probiotics is an important method to restore the ecological balance of intestinal microorganisms. Probiotics can maintain the balance of intestinal microecology and the integrity of intestinal mucosal barrier by inhibiting the growth of harmful bacteria, stimulating fermentation, stimulating the proliferation of intestinal mucosal cells and activating the immune system.

The preliminary study of this project has shown that the difference of intestinal flora in patients with HCC has a certain impact on the recovery speed of liver function after hepatectomy, and the core flora affecting postoperative liver function is bifidobacteria. Meanwhile, animal experiments have also verified that bifidobacteria can improve the postoperative liver function of mice. Therefore, improving the structure and environment of intestinal microorganisms, increasing the colonization of beneficial bacteria and enhancing the diversity of bacteria are very important to accelerate the recovery of liver function after hepatectomy for patients with HCC.

In this project, it is planned to use bifidobacteria-rich BIFICO as an intervention drug to sustained medication in the perioperative period of hepatectomy patients with HCC, and observe the recovery of postoperative liver function.

Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

The liver function recovery of the two groups on the fifth day after surgery was compared, and t-test was used to verify whether there was a significant difference between the two groups. Total bilirubin and prothrombin activity were used to assess liver function.

We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between two groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.

We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample; the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between the two groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Probiotics Combined With Chemotherapy for Patients With Advanced NSCLC	NCT03642548	Probiotics Plus...	bifico placebo	18 Years - 75 Years	Shanghai 10th People's Hospital
Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma	NCT05178524	Gut Microbiota Hepatocellular ... Bifidobacterium	BIFICO	18 Years - 80 Years	Tongji Hospital

Spots Global Cancer Trial Database for bifico

Every month we try and update this database with for bifico cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bifico

Every month we try and update this database with for bifico cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bifico cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.