NCT06563934Not yet recruitingPhase 2
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
A Randomized Controlled Trial Evaluating the Effects of Oral Enterobacterial Capsules in Liver Cancer Patients Treated With Tyrosine Kinase Inhibitors (TKIs) in Combination With Immune Checkpoint Inhibitors (ICIs)
Source: ClinicalTrials.gov · Last updated 21 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the additional efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced liver cancer and treated with tyrosine kinase inhibitors (TKIs) combined with immunotherapy.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 13 Aug 2024
- Start date
- 30 Aug 2024
- Primary completion date
- 20 May 2026
- Lead sponsor
- Xu Yong, MD
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06563934
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 30 Aug 2024 to the primary completion date, 20 May 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Usage of antibiotics within 2 weeks prior enrollment;
- Those who are currently undergoing clinical trials of other drugs;
Other illness
- Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
Other
- Female patients who are pregnant or breastfeeding;
- Other patients who are considered by the investigator to be unsuitable for inclusion.
Who the study is looking for
- Age 18-75 years old, gender is not limited;
- Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;
- Previous treatment without systemic therapy;
- Intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors;
- Child-Pugh Grade A;
- ≥ 1 measurable lesion (RECIST v1.1)
- ECOG PS 0-1
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.