Liver CancerPhase 2NCT06563934
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
A Phase 2 study testing Oral enterobacterium capsules and Lenvatinib + PD-1 monoclonal antibody in people with Liver Cancer, run by Xu Yong, MD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Oral enterobacterium capsules and Lenvatinib + PD-1 monoclonal antibody
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 20 Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Liver Cancer
- Being tested
- Oral enterobacterium capsules, Lenvatinib + PD-1 monoclonal antibody, Oral enterobacterium capsules placebo
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral enterobacterium capsulesBiological
Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.
Lenvatinib + PD-1 monoclonal antibodyDrug
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 placeboBiological
Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules | Experimental | 1. 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.
2. Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment. Receives: Biological: Oral enterobacterium capsules; Drug: Lenvatinib + PD-1 monoclonal antibody |
| Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo | Placebo comparator | 1. 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.
2. Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment. Receives: Drug: Lenvatinib + PD-1 monoclonal antibody; Biological: Oral enterobacterium capsules placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Progression-Free Survival (PFS)
To analyse the Progression-Free Survival (PFS) of patients
Measured: Up to approximately 1 years
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
Measured: Up to approximately 1 years
Objective Objective Response Rate (ORR)
To exprole the Objective Response Rate (ORR) of patients
Measured: Up to approximately 1 years
ObjectiveDuration of Response (DOR)
To analyse the Duration of Response (DOR) of patients
Measured: Up to approximately 1 years
Diversity analysis
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.
Measured: Up to approximately 1 years
Species differential analysis
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.
Measured: Up to approximately 1 years
Feces Metabolomics
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.
Measured: Up to approximately 1 years
Serum Metabolomics
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.
Measured: Up to approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start30 Aug 2024 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xu Yong, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Xiershou Biotechnology Co., Ltd
- Responsible party
- Sponsor-investigator, Xu Yong, MD, Shenzhen Third People's Hospital
- Investigators
- Yong Xu, Dr, Principal investigator, Secretary of the Party Committee of the Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563934
- Sponsor's protocol ID
- KY2024-177
- Status last verified
- Aug 2024
- First submitted
- 13 Aug 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06563934
- Acronym / sponsor ID
- KY2024-177
- Conditions
- Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Xu Yong, MDUniversity, hospital or other
- Collaborators
- Nanjing Xiershou Biotechnology Co., Ltd
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules | Experimental | Biological: Oral enterobacterium capsules, Drug: Lenvatinib + PD-1 monoclonal antibody1. 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. 2. Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment. |
| Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo | Placebo comparator | Drug: Lenvatinib + PD-1 monoclonal antibody, Biological: Oral enterobacterium capsules placebo1. 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. 2. Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral enterobacterium capsulesEnterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days. | Biological | Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules |
| Lenvatinib + PD-1 monoclonal antibodyLenvatinib 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. | Drug | Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules, Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo |
| Oral enterobacterium capsules placeboEnterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days. | Biological | Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo |
Primary outcome
Objective Progression-Free Survival (PFS)
Time frame: Up to approximately 1 years
To analyse the Progression-Free Survival (PFS) of patients
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
Objective Objective Response Rate (ORR)
Time frame: Up to approximately 1 years
To exprole the Objective Response Rate (ORR) of patients
ObjectiveDuration of Response (DOR)
Time frame: Up to approximately 1 years
To analyse the Duration of Response (DOR) of patients
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Xu, Dr principal investigator
Secretary of the Party Committee of the Shenzhen Third People's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral enterobacterium capsules and Lenvatinib + PD-1 monoclonal antibody in people with Liver Cancer, run by Xu Yong, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongmei Gou, Dr (13696020717, gdm4726@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Progression-Free Survival (PFS) (time frame: Up to approximately 1 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.