To hear about similar clinical trials, please enter your email below
Trial Title:
a Cohort Study (Gut Microbiota and HCC)
NCT ID:
NCT06557213
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Detailed description:
This is a prospective, observational cohort study. Patients with intermediate and
advanced hepatocellular carcinoma who meet the enrollment and exclusion criteria are
judged to be unresectable after evaluation by professional physicians, and are intended
to be treated with anti-angiogenic targeted drugs combined with immune checkpoint
inhibitors. During the treatment according to clinical needs, stool and blood samples
were taken regularly, and the treatment response of patients was judged according to
RECIST V1.1 criteria, and the common adverse reactions during treatment were evaluated by
the CTCAE5.0 grading system, and the relationship between intestinal microbiota and liver
cancer treatment response was analyzed.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age 18-75 years old, gender unlimited
2. Diagnosed as HCC through pathological or clinical examination
3. BCLC Phase B or C
4. Previously without systematic treatment
5. Irremovable
6. Intended to receive targeted anti-angiogenic drugs combined with immune checkpoint
inhibitors for treatment
7. ≥ 1 measurable lesion (RECIST V1.1)
8. ECOG PS 0-1
9. The subjects voluntarily joined this study, signed an informed consent form, had
good compliance, and cooperated with follow-up.
Exclusion Criteria:
1. Received attenuated live vaccine within 4 weeks prior to enrollment or planned
during the study period
2. Active, known or suspected autoimmune diseases
3. Known history of primary immunodeficiency
4. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem
cell transplantation
5. Pregnant or lactating female patients
6. Uncontrolled concurrent diseases
7. Currently conducting clinical trials for other drugs
8. Other patients deemed unsuitable for inclusion by researchers
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 30, 2024
Completion date:
November 20, 2026
Lead sponsor:
Agency:
Xu Yong, MD
Agency class:
Other
Collaborator:
Agency:
Nanjing Xiershou Biotechnology Co., Ltd
Agency class:
Other
Source:
Shenzhen Third People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06557213
