a Cohort Study (Gut Microbiota and HCC)

NCT ID: NCT06557213

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-08-30
• Study Completion Date: 2026-11-20

Brief 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.

Conditions

Liver Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Xiershou Biotechnology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

Xu Yong, MD

OTHER

Sponsor Role: lead

Responsible Party

Xu Yong, MD

Secretary of the Party Committee

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong Xu, Dr

Role: STUDY_CHAIR

Secretary of the Party Committee of the Shenzhen Third People's Hospital

Central Contacts

Dongmei Gou, Dr

Role: CONTACT

gdm4726@163.com

13696020717

Other Identifiers

KY2024-176

Identifier Type: -

Identifier Source: org_study_id