Fecal Microbiota Transplantation to RESCUE Patients With Unresectable Hcc Progressors to First Line Therapy With AtezolizUmaB and Bevacizumab
Objective: To determine whether FMT can restore or enhance response to atezolizumab and bevacizumab following disease progression. Participants will: Receive a fecal microbiota transplantation (FMT). Resume treatment with atezolizumab and bevacizumab, administered every 3 weeks.
• Signed Informed Consent Form.
• Age ≥ 18 years.
• Tolerance to first-line treatment for HCC with atezolizumab plus bevacizumab, defined as absence of adverse events requiring permanent discontinuation of either drug.
• Ability to comply with all study procedures, in the investigator's judgment.
• Unresectable hepatocellular carcinoma with early disease progression on first-line atezolizumab + bevacizumab (within 4 months of treatment initiation).
• At least one untreated measurable lesion per RECIST 1.1.
• ECOG Performance Status 0-1.
• Child-Pugh class A.
• Adequate hematologic and end-organ function (laboratory values obtained within 7 days prior to enrollment), defined as follows:
∙ ANC ≥ 1.5 × 10⁹/L (1500/µL), without G-CSF support.
‣ Lymphocyte count ≥ 0.5 × 10⁹/L (500/µL).
‣ Platelet count ≥ 60 × 10⁹/L (60,000/µL), without transfusion.
‣ Hemoglobin ≥ 90 g/L (9 g/dL); transfusion allowed if last transfusion ≥ 3 weeks prior.
‣ AST, ALT, and ALP ≤ 5 × ULN.
‣ Total bilirubin ≤ 3 × ULN.
‣ Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min (Cockcroft-Gault).
‣ Serum albumin ≥ 28 g/L (2.8 g/dL), without infusion supplementation in previous 2 months.
‣ INR and aPTT ≤ 1.5 × ULN.
⁃ Women of childbearing potential:
⁃ a. Agree to remain abstinent or use effective contraception (failure rate \<1%/year) during treatment and for 5 months after last atezolizumab dose and 6 months after last bevacizumab dose.
⁃ b. Agree to refrain from donating eggs during this period.
⁃ Men with female partners of childbearing potential:
• Agree to remain abstinent or use a condom plus an additional contraceptive method (combined failure rate \<1%/year) during treatment and for 6 months after last bevacizumab dose.
∙ Agree to refrain from donating sperm during this period.