Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)

Launched by FUJIAN PROVINCIAL HOSPITAL · Oct 13, 2024

Keywords

ClinConnect Summary

This clinical trial, called TALENP004, is exploring a new treatment approach for patients with a serious liver cancer known as unresectable hepatocellular carcinoma (HCC), which means the cancer cannot be surgically removed. The study is testing whether fecal microbiota transplantation (FMT) can help patients who have not responded to a combination therapy called triple therapy, which includes specific cancer-fighting medications and procedures. By using FMT, researchers hope to improve the effectiveness of this treatment and help patients whose cancer has continued to progress.

To take part in this trial, participants must be between 18 and 75 years old and have advanced liver cancer that has not improved after receiving the triple therapy. They should have measurable tumors that can be evaluated, and their overall health must meet certain criteria, such as having stable liver function. The trial will involve 15 patients who will receive FMT capsules prepared from healthy donors, and researchers will monitor how well this new treatment works and any side effects that may occur. This study is currently not recruiting participants, so if you or someone you know is interested, it’s important to stay informed about when enrollment begins.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with intermediate to advanced Hepatocellular Carcinoma (HCC) who have experienced disease progression (PD) after treatment with the triple therapy of Transarterial Chemoembolization (TACE), lenvatinib, and sintilimab.
• • 2. Patients must have at least one measurable lesion according to the mRECIST 1.1 criteria (the longest diameter of measurable lesions on CT/MRI scan ≥10mm).
• • 3. Expected survival time greater than 3 months.
• • 4. No prior treatment with Fecal Microbiota Transplantation (FMT).
• • 5. No history of taking probiotics after the diagnosis of HCC.
• • 6. Child-Pugh class A/B.
• • 7. ECOG performance status: ≤1.
• • 8. Age between 18 and 75 years old.
• • 9. No other antitumor treatments except the triple therapy before enrollment.
• 10. Key organ function indicators meet the following requirements:
• • Hematology: Absolute neutrophil count ≥1.5×10\^9/L, Hb ≥9.0g/L, Platelets ≥75×10\^9/L Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage for obstructive jaundice); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤5 times ULN, Albumin ≥30g/L Renal function: Serum creatinine ≤1.5mg/dL, Creatinine clearance rate ≥60ml/min Coagulation function: International normalized ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 times ULN
• • 11. No history of severe arrhythmias, heart failure, severe ventilatory dysfunction, or severe pulmonary infections.
• • 12. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment, with a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breastfeeding. Men must agree to use contraceptive measures during the study period and for 6 months after the end of the study.
• Exclusion Criteria:
• • 1. Mixed hepatocellular-cholangiocarcinoma.
• • 2. Severe tumor progression (tumor volume occupies two-thirds or more of the liver volume or diffuse intrahepatic lesions).
• • 3. History of allergy to PD-1, lenvatinib, or their components.
• • 4. History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer.
• • 5. Patients who have undergone organ transplantation or are planning to undergo organ transplantation.
• • 6. Any active autoimmune disease or autoimmune disease with expected recurrence (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes).
• • 7. History of immunodeficiency; patients who are using immunosuppressants or systemic corticosteroid therapy for immunosuppression and have continued use within 2 weeks before signing the informed consent.
• • 8. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombotic tendencies, such as hemophilia patients; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed).
• • 9. Serious infections within 4 weeks before enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicates active pulmonary inflammation, presence of infection symptoms and signs or need for oral or intravenous antibiotic treatment within 2 weeks before the first use of the study drug (excluding the use of antibiotics for prevention).
• • 10. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction.
• • 11. Chronic intestinal diseases (such as celiac disease, malabsorption, etc.).
• • 12. Pregnant or breastfeeding women.
• • 13. Deemed by the investigator to be unsuitable for participation in this trial for other reasons.