Status:
NOT_YET_RECRUITING
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
Lead Sponsor:
Xu Yong, MD
Collaborating Sponsors:
Nanjing Xiershou Biotechnology Co., Ltd
Conditions:
Liver Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
This is a prospective, single-center, randomized, double-blind controlled trial. The clinical study is divided into 2 groups: Group 1) Patients in the control group were given lenvatinib 8mg (≤ 60 kg...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Usage of antibiotics within 2 weeks prior enrollment;
- Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Female patients who are pregnant or breastfeeding;
- Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.
- Those who are currently undergoing clinical trials of other drugs;
- Other patients who are considered by the investigator to be unsuitable for inclusion.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06563934
Start Date
August 30 2024
End Date
November 20 2026
Last Update
August 21 2024
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