Clinical trial NCT06557213: a Cohort Study (Gut Microbiota and HCC)
Official title: Prediction of Liver Cancer Treatment Response Based on Gut Microbiota: a Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Cancer
Lead sponsor: Shenzhen Third People's Hospital
Sponsor class: OTHER
Collaborators: name: Nanjing Xiershou Biotechnology Co., Ltd
First posted: 2024-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Progression-Free Survival (PFS)
timeFrame: Up to approximately 1 years
measure: Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
timeFrame: Up to approximately 1 years
measure: Objective Objective Response Rate (ORR)
timeFrame: Up to approximately 1 years
measure: ObjectiveDuration of Response (DOR)
timeFrame: Up to approximately 1 years
measure: Diversity analysis
timeFrame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
measure: Species differential analysis
timeFrame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
measure: Feces Metabolomics
timeFrame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
measure: Serum Metabolomics
timeFrame: 0 weeks, 12 weeks, 24 weeks and 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Secretary of the Party Committee of the Shenzhen Third People's Hospital
name: Yong Xu, Dr
role: STUDY_CHAIR
References: