Oral FMT Capsules Added to ICI-TKI Therapy in Advanced HCC After Progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm phase 2 trial in adults with unresectable advanced HCC who progressed on prior ICI-TKI therapy. Participants continue their prescribed ICI-TKI regimen and receive oral FMT capsules (300 mg per capsule, 6 capsules daily) for 10 days in each 21-day cycle, for up to 4 cycles. The study's primary endpoint is progression-free survival, measured from the first FMT dose to radiographic progression or death. Secondary endpoints include overall survival, objective response rate, and duration of response. The trial aims to assess safety and potential efficacy of augmenting standard therapy with FMT in this setting.

Why it matters

Who can join: the full rules

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 class A or B, with a score of ≤7;
6. ≥ 1 measurable lesion (RECIST v1.1)
7. ECOG PS 0-2

Exclusion Criteria:

1. Use of antibiotics within 4 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.

Where it's running

• Shenzhen Third People's Hospital
  Shenzhen, China Recruiting

Study contacts

• Principal investigator: Yong Xu, Dr — Secretary of the Party Committee of the Shenzhen Third People's Hospital
• Study coordinator: Cineng Xu, Dr
• Email: 822265652@qq.com
• Phone: 13530871434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.