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NCT06563947

Single Arm Clinical Trial (Gut Microbiota and HCC)

Traducción pendiente · disponible pronto
Aún no reclutando Fase 2

Descripción

To evaluate the efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination with anti-angiogenesis targeted agents.

Criterios de Elegibilidad

Inclusion Criteria:

1. Age 18-75 years old, gender is not limited;

2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;

3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;

4. Not suitable for local ablation or chemoembolization;

5. Child-Pugh Grade A;

6. ≥ 1 measurable lesion (RECIST v1.1)

7. ECOG PS 0-1

Exclusion Criteria:

1. Usage of antibiotics within 2 weeks prior enrollment;

2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)

3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;

4. Female patients who are pregnant or breastfeeding;

5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.

6. Patients are currently undergoing clinical trials of other drugs;

7. Patients are considered by the investigator to be unsuitable for inclusion.

Información del Ensayo

NCT06563947
Aún no reclutando
Fase 2
30 participantes
Ago 2024
May 2026