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Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
Sponsor: Xu Yong, MD
Summary
To evaluate the additional efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced liver cancer and treated with tyrosine kinase inhibitors (TKIs) combined with immunotherapy.
Official title: A Randomized Controlled Trial Evaluating the Effects of Oral Enterobacterial Capsules in Liver Cancer Patients Treated With Tyrosine Kinase Inhibitors (TKIs) in Combination With Immune Checkpoint Inhibitors (ICIs)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2024-08-30
Completion Date
2026-11-20
Last Updated
2024-08-21
Healthy Volunteers
No
Conditions
Interventions
Oral enterobacterium capsules
Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.
Lenvatinib + PD-1 monoclonal antibody
Lenvatinib 8mg (≤60 kg body weight) or 12 mg (\> 60 kg body weight) orally once a day. PD-1 monoclonal antibody 200mg i.v. once every 3 weeks.
Oral enterobacterium capsules placebo
Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.