Health Condition 1: C220- Liver cell carcinoma
Conditions
Interventions
Intervention1: Fecal microbiota transplantation plus systemic therapy: Single session of fecal microbiota transplantation (donor being healthy patients) delivered into duodenum via UGI endoscopy, foll
Sponsors
All India Institute of Medical Sciences , New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Radiologically or histologically confirmed Hepatocellular carcinoma 3. Barcelona Clinic Liver Cancer stage C 4. ECOG performance status 0-2 5. Child pugh class A5-B8 6. Adequate hematological and end-organ function, defined as follows: a. AST and ALT less than 5 x ULN b. Serum bilirubin less than 3 mg/dL c. Serum creatinine less than or equal to 1.5 mg/dL d. Hemoglobin more than or equal to 8 mg/dL e. Platelet count more than or equal to 50k f. Leukocytes more than or equal to 2500 7. Written informed consent
Exclusion criteria
Exclusion criteria: A. Known fibrolamellar carcinoma or mixed cholangiocellular carcinoma B. Concomitant other malignancies C. Uncontrolled ascites D. Overt hepatic encephalopathy or concomitant treatment with rifaximin E. Not able to undergo UGI endoscopy F. Prior locoregional therapy G. Prior allogeneic stem cell or solid organ transplantation H. Recent antibiotic use within 2 months I. Prior history of fecal microbiota transplantation J. Active or history of severe autoimmune disease K. Severe infection within 4 weeks prior to study inclusion L. Active infection at the time of enrollment M. Pregnant or breastfeeding women N. Treatment with systemic immunosuppressive medication with the following exceptions: a. Acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for contrast allergy) b. Mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease or asthma, or low-dose corticosteroids for adrenal insufficiency O. Major surgery within 4 weeks prior to study inclusion or minor surgery (excluding placement of a vascular access device) within 3 days prior to study inclusion P. History of gastrointestinal fistula or perforation, or intra-abdominal abscess within 6 months prior to study inclusion Q. Serious, non-healing wound or active ulcer R. Any clinical or laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of FMT in combination with systemic therapy, assessed by the number of study participants achieving complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) as best overall response evaluated according to mRECIST criteriaTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of FMT in combination with systemic therapy, assessed by objective response rate (ORR) and disease control rate (DCR)Timepoint: 6 months;Efficacy of FMT in combination with systemic therapy, assessed by progression-free survival (PFS) and overall survival (OS).Timepoint: 24 months;Safety of FMT in combination with systemic therapy, measured by incidence and severity of treatment-related adverse events, determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.5.0Timepoint: 6 months;Effect of FMT on recipient gut microbiota composition and diversity (alpha and beta), rate of change from baseline and similarity to donor stool composition over timeTimepoint: 2 months;Differences in circulating immune cells and microbial metabolites in patients before and after FMT.Timepoint: 2 months;Quality of life as reported by EORTC QLQ-C30 and QLQ-HCC18Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Shalimar
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed