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NOT YET RECRUITING
NCT06563934
PHASE2

Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)

Sponsor: Xu Yong, MD

View on ClinicalTrials.gov

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

BIOLOGICAL

Oral enterobacterium capsules

Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.

DRUG

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.

BIOLOGICAL

Oral enterobacterium capsules placebo

Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.