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NCT07847671
Fecal Microbiota Transplantation Combined With QL1706 Plus Bevacizumab for Advanced HCC
Conditions: Advanced Hepatocellular Carcinoma (HCC)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Tianjin Medical University Cancer Institute and Hospital
Location: Tianjin Medical University Cancer Institute and Hospital Tianjin
Summary
This is a prospective, single-center, single-arm Phase II pilot study designed to evaluate the efficacy and safety of FMT in combination with QL1706 and Bevacizumab as first-line treatment for advanced Hepatocellular carcinoma.
Eligibility Criteria
Inclusion Criteria:
* Age \>18 years.
* Confirmed imaging or histological diagnosis of unresectable HCC.
* Treatment-naïve unresectable or metastatic HCC.
* BCLC Stage C.
* Child-Pugh A.
* ECOG PS 0-1.
Exclusion Criteria:
* Prior treatment with an immune checkpoint inhibitor, or prior systemic therapy for advanced HCC.
* Histologic subtypes other than hepatocellular carcinoma, including fibrolamellar HCC, sarcomatoid HCC, and mixed hepatocellular cholangiocarcinoma.
* Active or prior autoimmune disease, immunodeficiency requiring systemic immunosuppressive therapy.
* Clinically significant bleeding risk, coagulopathy, or untreated high-risk esophagogastric varices.
* Any contraindication to fecal microbiota transplantation.
* Uncontrolled intercurrent illness, including active infection, clinically significant cardiovascular disease, central nervous system metastases.
* Pregnancy or breastfeeding.
Source: ClinicalTrials.gov (NCT07847671). StuddyBuddy aggregates publicly available trial information.