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

NCT06563934 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-08-21

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Nanjing Xiershou Biotechnology Co., Ltd

    collaborator UNKNOWN

  • Xu Yong, MD

    lead OTHER

Principal Investigators

  • Yong Xu, Dr · Secretary of the Party Committee of the Shenzhen Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2026-05-20
Completion
2026-11-20

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06563934 on ClinicalTrials.gov