a Cohort Study (Gut Microbiota and HCC)

Xu Yong, MD

Status: Not yet enrolling

Conditions: Liver Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06557213

KY2024-176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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