Single Arm Clinical Trial (Gut Microbiota and HCC)

NCT ID: NCT06563947

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-24
• Study Completion Date: 2026-11-20

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 with anti-angiogenesis targeted agents.

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 targeted drugs will remain unchanged after enrollment.On this basis, the study subjects started oral enterobacterial capsules to see whther enterobacterial capsules could improve the efficacy of patients receiving the above treatment regimens.

Oral administration of intestinal bacteria capsules 6 capsules/day, after observing no adverse reactions, oral administration for 10 consecutive days, 6 capsules/day from the second day to the tenth day, and then discontinued to the next course of treatment.

Total course of treatment: a total of 4 courses of oral intestinal bacteria capsules, each course of oral administration for 10 days, and a course of 21 days; A course of TKI combined with immune checkpoint inhibitors treatment is 21 days until the disease progresses or intolerable toxicity and side effects appear.

Observe the metrics: Primary Clinical Endpoint - Progression-Free Survival (PFS); Secondary Clinical Endpoints - Overall Growth Phase (OS), Objective Response Rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR). The new RECIST1.1 criteria were used for the efficacy evaluation system, the CTCAE5.0 grading system was used for the evaluation of common adverse reactions during treatment, and other indicators included imaging including conventional biochemical indexes such as CT and ultrasound, as well as quality of life scores.

Conditions

Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with progressed HCC after treatment were given enterobacterium capsules

Patients were given oral enterobacterium capsules (300 mg/per capsule) 6 capsules/day for 10 consecutive days, and then discontinued to the next course of treatment.

Group Type: EXPERIMENTAL

Oral enterobacterium capsules

Intervention Type: BIOLOGICAL

Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.

Interventions

Oral enterobacterium capsules

Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive days.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years old, gender is not limited;

2. Confirmed imaging or histological diagnosis of unresectable HCC, BCLC stadium B or C;

3. Clinical diagnosis of HCC progression during TKIs combined with ICIs treatment;

4. Not suitable for local ablation or chemoembolization;

5. Child-Pugh Grade A;

6. ≥ 1 measurable lesion (RECIST v1.1)

7. ECOG PS 0-1

Exclusion Criteria

1. Usage of antibiotics within 2 weeks prior enrollment;

2. Diagnosis of immunodeficiency (e.g. HIV, immunosuppressants)

3. Patients with known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;

4. Female patients who are pregnant or breastfeeding;

5. Patients with untreated acute or chronic active hepatitis B or hepatitis C infection.

6. Patients are currently undergoing clinical trials of other drugs;

7. Patients are considered by the investigator to be unsuitable for inclusion.

• 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 & Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yong Xu, Dr

Role: PRINCIPAL_INVESTIGATOR

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

KY2024-178

Identifier Type: -

Identifier Source: org_study_id