a Cohort Study (Gut Microbiota and HCC)
ConditionLiver Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorXu Yong, MD
About this trial
To analyze the predictive role of intestinal microbiota in tyrosine kinase inhibitors (TKIs) combined with immunotherapy response in patients with intermediate and advanced liver cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years old, gender unlimited
Diagnosed as HCC through pathological or clinical examination
BCLC Phase B or C
Previously without systematic treatment
Disqualifiers
Received attenuated live vaccine within 4 weeks prior to enrollment or planned during the study period
Active, known or suspected autoimmune diseases
Known history of primary immunodeficiency
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Trial population
This is a prospective, observational cohort study. Patients with advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria, who are judged to be unresectable after evaluation by professional physicians, are planned to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors, and according to the number of such patients in Shenzhen Third People's Hospital in the case year, this study intends to include 100 study subjects
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Objective Progression-Free Survival (PFS)
To analyse the Progression-Free Survival (PFS) of patients
Time frame
Up to approximately 1 years2
Objective Secondary Clinical Endpoints - Overall Growth Phase (OS)
To analyse the Secondary Clinical Endpoints - Overall Growth Phase (OS) of patients
Time frame
Up to approximately 1 years3
Objective Objective Response Rate (ORR)
To exprole the Objective Response Rate (ORR) of patients
Time frame
Up to approximately 1 years4
ObjectiveDuration of Response (DOR)
To analyse the Duration of Response (DOR) of patients
Time frame
Up to approximately 1 yearsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Xu Yong, MD
Lead sponsor
Shenzhen Third People's Hospital
Sponsor institution
Nanjing Xiershou Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: