Liver Cancer
Conditions
Brief 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.
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.
Interventions
None listed
Sponsors
Nanjing Xiershou Biotechnology Co., Ltd
Xu Yong, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-75 years old, gender unlimited 2. Diagnosed as HCC through pathological or clinical examination 3. BCLC Phase B or C 4. Previously without systematic treatment 5. Irremovable 6. Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint inhibitors for treatment 7. ≥ 1 measurable lesion (RECIST V1.1) 8. ECOG PS 0-1 9. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
1. Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period 2. Active, known or suspected autoimmune diseases 3. Known history of primary immunodeficiency 4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation 5. Pregnant or lactating female patients 6. Uncontrolled concurrent diseases 7. Currently conducting clinical trials for other drugs 8. Other patients deemed unsuitable for inclusion by researchers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Progression-Free Survival (PFS) | Up to approximately 1 years | To analyse the Progression-Free Survival (PFS) of patients |
| Objective Secondary Clinical Endpoints - Overall Growth Phase (OS) | Up to approximately 1 years | To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients |
| Objective Objective Response Rate (ORR) | Up to approximately 1 years | To exprole the Objective Response Rate (ORR) of patients |
| ObjectiveDuration of Response (DOR) | Up to approximately 1 years | To analyse the Duration of Response (DOR) of patients |
| Diversity analysis | 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 | 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 | 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 | 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. |
Contacts
Primary ContactDongmei Gou, Dr
Outcome results
None listed