Can radiotherapy and poop pills outsmart liver cancer resistance?
NCT ID NCT07463248
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
This Phase 2 trial tests whether adding personalized radiotherapy (PULSAR) and fecal microbiota transplants (FMT) to standard targeted-immunotherapy can reverse resistance in advanced liver cancer. About 64 patients whose cancer stopped responding to first-line treatment will be randomly assigned to either the new combo or a second-line drug switch. The goal is to see if this approach improves how long patients live without their cancer growing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tislelizumab, tyrosine kinase inhibitors (lenvatinib, donafenib, apatinib, sorafenib, regorafenib), fecal microbiota transplantation, and personalized radiotherapy (PULSAR)
- What this could lead to
- If successful, this approach could offer a new way to overcome drug resistance in advanced liver cancer, potentially extending life for patients who stop responding to standard treatment.
- What could go wrong
- This is a small Phase 2 trial with only 64 participants, so results may not apply to all patients. The combination of treatments may cause side effects, and the benefit over standard second-line therapy is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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West China Hospital
RECRUITINGChengdu, Sichuan, 610041, China
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