a Cohort Study (Gut Microbiota and HCC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
Overview
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.
Primary outcome measures
- Objective Progression-Free Survival (PFS) [Time frame: Up to approximately 1 years]
- Objective Secondary Clinical Endpoints - Overall Growth Phase (OS) [Time frame: Up to approximately 1 years]
- Objective Objective Response Rate (ORR) [Time frame: Up to approximately 1 years]
- ObjectiveDuration of Response (DOR) [Time frame: Up to approximately 1 years]
- Diversity analysis [Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks]
- Species differential analysis [Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks]
- Feces Metabolomics [Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks]
- Serum Metabolomics [Time frame: 0 weeks, 12 weeks, 24 weeks and 48 weeks]
Eligibility criteria
Inclusion criteria
- 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
- ≥ 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06557213 · KY2024-176