PULSAR plus Fecal Microbiota Transplantation for advanced HCC after targeted-immunotherapy

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 Phase 2, open-label, multicenter trial compares continuing the first-line targeted-immunotherapy regimen with the addition of fecal microbiota transplantation and the PULSAR radiotherapy approach against switching to a second-line targeted-immunotherapy regimen in patients who progressed after initial disease control. Primary endpoint is progression-free survival, with secondary endpoints including overall survival, response rates, disease control, safety, and exploratory biomarker analyses of gut microbiota and tumor immune microenvironment. The study seeks to determine if modifying the gut microbiota and applying PULSAR can enhance immunotherapy efficacy and reverse resistance when combined with radiotherapy. Eligible patients have unresectable HCC, BCLC B/C, prior disease control on first-line therapy, Child-Pugh ≤7, measurable disease, and good performance status.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Clinically or pathologically confirmed unresectable primary hepatocellular carcinoma;
2. Liver cancer patients with BCLC stage B or C;
3. Not receiving systematic treatment before enrollment;
4. Patients with acquired resistance who achieved disease control (DCR: CR, PR, or SD) following first-line targeted-immunotherapy but later experienced disease progression (PD);
5. Child Pugh score ≤ 7 points;
6. Subject must have at least 1 measurable target lesion examined by CT or MRI according to RECIST1.1 criteria;
7. The Eastern Oncology Consortium (ECOG) Behavioral status score was 0 or 1.

Key Exclusion Criteria:

1. Failure to recover to NCI-CTC AE Grade ≤1 (excluding alopecia and fatigue) or to baseline level from toxicities and/or complications of prior interventions before PD-1 monoclonal antibody re-challenge;
2. Subjects requiring systemic therapy with corticosteroids (\>10 mg prednisone equivalent daily) or other immunosuppressive agents within 14 days prior to PD-1 monoclonal antibody re-challenge；
3. Received abdominal radiotherapy or administered radioactive substances within 28 days prior to PD-1 monoclonal antibody re-challenge;
4. History of gastrointestinal perforation and/or fistula within 6 months prior to PD-1 monoclonal antibody re-challenge;
5. Active gastrointestinal bleeding within 1 week before the first fecal microbiota transplantation.
6. Occurrence of infection within 28 days prior to PD-1 monoclonal antibody re-challenge;
7. Active infection requiring systemic antimicrobial therapy before PD-1 monoclonal antibody re-challenge and intestinal microbiota transplantation, excluding local infections requiring only topical antibiotics (e.g., skin infections);
8. Received live or attenuated vaccines within 30 days prior to PD-1 monoclonal antibody re-challenge, or planned vaccination during the study period;
9. Known history of primary immunodeficiency or HIV infection;
10. Active or previously documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, chronic diarrhea), except patients with chronic diarrhea who had no recurrence within 2 years before enrollment;
11. Known history of active tuberculosis (TB)；
12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
13. Suffering from active, known or suspected autoimmune disease, or with a history of autoimmune disease;
14. History of cardiovascular or cerebrovascular events or accidents within 6 months;
15. Other conditions deemed by the investigator to be inappropriate for enrollment, including patients with hyperprogressive disease.

Where it's running

• West China Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Xin Wang
• Email: wangxin213@sina.com
• Phone: +86 28 85423609

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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.