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NCT Number: NCT06563934

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

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

This is a prospective, single-center, randomized, double-blind controlled trial. The clinical study is divided into 2 groups:

Group 1) Patients in the control group were given lenvatinib 8mg (≤ 60 kg body weight) or 12 mg (> 60 kg body weight) orally once a day, combined with PD-1 monoclonal antibody 200mg intravenously once every 3 weeks until disease progression, intolerable toxicity or death, and patients in the control group were given intestinal bacteria capsules placebo.

Group 2) Patients in the study group were given lenvatinib 8 mg (≤ 60 kg body weight) or 12 mg (> 60 kg body weight) orally once a day in combination with PD-1 monoclonal antibody 200 mg intravenously every 3 weeks until disease progression, intolerable toxicity, or death, and patients in this study group were given intestinal bacteria capsules.

Oral administration of intestinal bacteria capsules 6 capsules/day, after observing no adverse reactions, oral administration for 10 consecutive days, 6 capsules/day from the second day to the tenth day, and then discontinued to the next course of treatment.

Total course of treatment: a total of 4 courses of oral intestinal bacteria capsules, each course of oral administration for 10 days, and a course of 21 days; A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear.

Observe the metrics: Primary Clinical Endpoint - Progression-Free Survival (PFS); Secondary Clinical Endpoints - Overall Growth Phase (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR). The new RECIST1.1 criteria were used for the efficacy evaluation system, the CTCAE5.0 grading system was used for the evaluation of common adverse reactions during treatment, and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound, as well as quality of life scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years old, gender is not limited;
  • Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
  • Previous treatment without systemic therapy;
  • Intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors;
  • Child-Pugh Grade A;
  • ≥ 1 measurable lesion (RECIST v1.1)
  • ECOG PS 0-1

Exclusion criteria

  • Usage of antibiotics within 2 weeks prior enrollment;
  • Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
  • Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • Female patients who are pregnant or breastfeeding;
  • Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
  • Those who are currently undergoing clinical trials of other drugs;
  • Other patients who are considered by the investigator to be unsuitable for inclusion.

Treatment and study plan

Oral enterobacterium capsules

Biological

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

Lenvatinib + PD-1 monoclonal antibody

Drug

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

Biological

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

Primary outcomes

  1. Objective Progression-Free Survival (PFS)

    Time frame: Up to approximately 1 years

    To analyse the Progression-Free Survival (PFS) of patients

  2. Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)

    Time frame: Up to approximately 1 years

    To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients

  3. Objective Objective Response Rate (ORR)

    Time frame: Up to approximately 1 years

    To exprole the Objective Response Rate (ORR) of patients

  4. ObjectiveDuration of Response (DOR)

    Time frame: Up to approximately 1 years

    To analyse the Duration of Response (DOR) of patients

  5. Diversity analysis

    Time frame: Up to approximately 1 years

    We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota 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.

  6. Species differential analysis

    Time frame: Up to approximately 1 years

    We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition.

  7. Feces Metabolomics

    Time frame: Up to approximately 1 years

    Changes of metabolites in feces measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.

  8. Serum Metabolomics

    Time frame: Up to approximately 1 years

    Changes of metabolites in serum measured by metabolomic mass spectrometry, unsupervised PCA (principal component analysis) was performed by statistics function prcomp, identified metabolites were annotated using KEGG Compound database.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongmei Gou, Dr

CONTACT

[email protected]

13696020717

Sponsors and collaborators

Lead sponsor

Xu Yong, MD

Other

Collaborators

  • Nanjing Xiershou Biotechnology Co., Ltd

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 21, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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