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Trial Title:
Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)
NCT ID:
NCT06563934
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Lenvatinib
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a prospective, single-center, randomized, double-blind controlled trial. The
clinical study is divided into 2 groups: Group 1) Patients in the control group were
given lenvatinib 8mg (≤ 60 kg body weight) or 12 mg (> 60 kg body weight) orally once a
day, combined with PD-1 monoclonal antibody 200mg intravenously once every 3 weeks until
disease progression, intolerable toxicity or death, and patients in the control group
were given intestinal bacteria capsules placebo. Group 2) Patients in the study group
were given lenvatinib 8 mg (≤ 60 kg body weight) or 12 mg (> 60 kg body weight) orally
once a day in combination with PD-1 monoclonal antibody 200 mg intravenously every 3
weeks until disease progression, intolerable toxicity, or death, and patients in this
study group were given intestinal bacteria capsules.
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
This is a prospective, single-center, randomized, double-blind controlled trial.
Intervention:
Intervention type:
Biological
Intervention name:
Oral enterobacterium capsules
Description:
Enterobacterium capsules (300 mg/per capsule) orally 6 capsules/day for 10 consecutive
days.
Arm group label:
Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules
Intervention type:
Drug
Intervention name:
Lenvatinib + PD-1 monoclonal antibody
Description:
Lenvatinib 8mg (≤60 kg body weight) or 12 mg (> 60 kg body weight) orally once a day.
PD-1 monoclonal antibody 200mg i.v. once every 3 weeks.
Arm group label:
Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules
Arm group label:
Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo
Intervention type:
Biological
Intervention name:
Oral enterobacterium capsules placebo
Description:
Enterobacterium capsules placebo (300 mg/per capsule) orally 6 capsules/day for 10
consecutive days.
Arm group label:
Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placebo
Summary:
To evaluate the additional efficacy and safety of oral enterobacterial capsules in
patients with intermediate and advanced liver cancer and treated with tyrosine kinase
inhibitors (TKIs) combined with immunotherapy.
Detailed description:
This is a prospective, single-center, randomized, double-blind controlled trial. The
clinical study is divided into 2 groups:
Group 1) Patients in the control group were given lenvatinib 8mg (≤ 60 kg body weight) or
12 mg (> 60 kg body weight) orally once a day, combined with PD-1 monoclonal antibody
200mg intravenously once every 3 weeks until disease progression, intolerable toxicity or
death, and patients in the control group were given intestinal bacteria capsules placebo.
Group 2) Patients in the study group were given lenvatinib 8 mg (≤ 60 kg body weight) or
12 mg (> 60 kg body weight) orally once a day in combination with PD-1 monoclonal
antibody 200 mg intravenously every 3 weeks until disease progression, intolerable
toxicity, or death, and patients in this study group were given intestinal bacteria
capsules.
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.
Criteria for 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. Previous treatment without systemic therapy;
4. Intended to be treated with anti-angiogenic targeted drugs combined with immune
checkpoint inhibitors;
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. 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. Those who are currently undergoing clinical trials of other drugs;
7. Other patients who are considered by the investigator to be unsuitable for
inclusion.
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/NCT06563934
