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Bifidobacterium

patients with advanced hepatocellular carcinoma who will be treate with carrilizumab and apatinib mesylate plus Bifidobacterium Bifidum Oral Product daily

patients with advanced hepatocellular carcinoma who will be treate with carrilizumab and apatinib mesylate without Bifidobacterium Bifidum Oral Product daily

experimental group use Bifidobacterium Bifidum Oral Product and control group without Bifidobacterium Bifidum Oral Product

Bifidobacterium Bifidum Oral Product

Chan Xie, PhD

Chan Xie, Dr.

This study plans to observe the changes of liver cancer and immune cell subsets by replicating the high abundance intestinal flora and liver cancer mouse model, reveal the relationship and mechanism of intestinal flora in the immunotherapy of liver cancer, and study the impact on prognosis by regulating the positive correlation of lactic acid bacteria and bifidobacteria of rumen coccus in patients with advanced liver cancer receiving immunotherapy

Select patients with advanced hepatocellular carcinoma who have been clinically consulted by MDT,those patients will be treated with carrilizumab and apatinib mesylate, and divide them into two groups randomly .Collect the stool specimens and clinical data from those who will be treated with oral bifidobacterium or without bifidobacterium during immunotherapy.; Use 16S sequencing to detect the changes in the composition ratio of intestinal flora and the level of galactose acid, judge the response to clinical treatment and establish the relationship curve with clinical treatment efficacy.

Select patients with advanced hepatocellular carcinoma who have been clinically consulted by MDT ,those patients will be treated with carrilizumab and apatinib mesylate,and divide them into two groups randomly .Collect the stool specimens and clinical data from those who will be treated with oral bifidobacterium or without bifidobacterium during immunotherapy.

Safety and Efficacy of Bifidobacterium Therapy in Patients With Advanced Liver Cancer Receiving Immunotherapy

Safety and Efficacy of Bifidobacterium Therapy in Patients With Advanced Liver Cancer Receiving Immunotherapy: a Randomized Controlled, Single-center Clinical Trial

The proportion of patients with tumor volume reduction up to a pre-specified value and able to maintain the minimum time requirement is the sum of the proportion in complete and partial remission

The number of cases with remission and stable lesions after treatment as a percentage of evaluable cases that were maintained for at least 4 weeks.

The time interval from the start of treatment until the patient's death (from any cause)

Time interval from the start of treatment until disease progression (including death)

The efficacy of the study will be evaluated based on the imaging results and evaluation criteria for efficacy of solid tumorssolid tumors (RECISTv1.1).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Bifidobacterium Therapy in Patients With Advanced Liver Cancer Receiving Immunotherapy	NCT05620004	Advanced Hepato...	Bifidobacterium...	18 Years - 65 Years	Sun Yat-sen University
Safety and Efficacy of Bifidobacterium Therapy in Patients With Advanced Liver Cancer Receiving Immunotherapy	NCT05620004	Advanced Hepato...	Bifidobacterium...	18 Years - 65 Years	Sun Yat-sen University
Safety and Efficacy of Bifidobacterium Therapy in Patients With Advanced Liver Cancer Receiving Immunotherapy	NCT05620004	Advanced Hepato...	Bifidobacterium...	18 Years - 65 Years	Sun Yat-sen University

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