Status:
NOT_YET_RECRUITING
a Cohort Study (Gut Microbiota and HCC)
Lead Sponsor:
Xu Yong, MD
Collaborating Sponsors:
Nanjing Xiershou Biotechnology Co., Ltd
Conditions:
Liver Cancer
Eligibility:
All Genders
18-75 years
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 20 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06557213
Start Date
August 30 2024
End Date
November 20 2026
Last Update
August 16 2024
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