Status:
NOT_YET_RECRUITING
Single Arm Clinical Trial (Gut Microbiota and HCC)
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 efficacy and safety of oral enterobacterial capsules in patients with intermediate and advanced HCC who have progressed after treating with immune checkpoint inhibitors in combination ...
Detailed Description
This is a prospective, single-center, single-arm clinical study. For those who meet the enrollment conditions, the original regimen of immune checkpoint inhibitors combined with anti-angiogenic target...
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;
- Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;
- Not suitable for local ablation or chemoembolization;
- 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)
- Patients with 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.
- Patients are currently undergoing clinical trials of other drugs;
- Patients are considered by the investigator to be unsuitable for inclusion.
Key Trial Info
Start Date :
August 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06563947
Start Date
August 24 2024
End Date
November 20 2026
Last Update
August 21 2024
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