Liver CancerNCT06557213
a Cohort Study (Gut Microbiota and HCC)
An observational study of Liver Cancer, run by Xu Yong, MD.
Trial summary
To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2024to 20 Nov 2026
- Phase
- Observational
- 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
Study population: This is a prospective, observational cohort study. Patients with advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria, who are judged to be unresectable after evaluation by professional physicians, are planned to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors, and according to the number of such patients in Shenzhen Third People's Hospital in the case year, this study intends to include 100 study subjects
Who may be able to join
- Age 18-75 years old, gender unlimited
- Diagnosed as HCC through pathological or clinical examination
- BCLC Phase B or C
- Previously without systematic treatment
- Irremovable
- Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment
Show all 9Show fewer
- ≥ 1 measurable lesion (RECIST V1.1)
- ECOG PS 0-1
- The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Who cannot join
- Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
- Active, known or suspected autoimmune diseases
- Known history of primary immunodeficiency
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Pregnant or lactating female patients
- Uncontrolled concurrent diseases
- Currently conducting clinical trials for other drugs
- Other patients deemed unsuitable for inclusion by researchers
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: Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.
Read the detailed description
This is a prospective, observational cohort study. Patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. During the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.
- Conditions
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 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, Study chair, Secretary of the Party Committee of the Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557213
- Sponsor's protocol ID
- KY2024-176
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 16 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
- ClinicalTrials.gov ID
- NCT06557213
- Acronym / sponsor ID
- KY2024-176
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 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
- 16 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 analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.
Detailed description
This is a prospective, observational cohort study. Patients with intermediate and advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are judged to be unresectable after evaluation by professional physicians, and are intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors. During the treatment according to clinical needs, stool and blood samples were taken regularly, and the treatment response of patients was judged according to RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver cancer treatment response was analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, observational cohort study. Patients with advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria, who are judged to be unresectable after evaluation by professional physicians, are planned to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors, and according to the number of such patients in Shenzhen Third People's Hospital in the case year, this study intends to include 100 study subjects
Key inclusion criteria (9 listed)
- Age 18-75 years old, gender unlimited
- Diagnosed as HCC through pathological or clinical examination
- BCLC Phase B or C
- Previously without systematic treatment
- Irremovable
Key exclusion criteria (8 listed)
- Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
- Active, known or suspected autoimmune diseases
- Known history of primary immunodeficiency
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- Pregnant or lactating female patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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: 0 weeks, 12 weeks, 24 weeks and 48 weeks
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 16 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 study chair
Secretary of the Party Committee of the Shenzhen Third People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of 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 9 inclusion and 8 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 16 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 16 Aug 2024.