Health TrialsbyHealthPanel

Gut Microbiota in Liver Cancer (Treated With TKIs In Combination With ICIs)

ConditionLiver Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXu Yong, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Previous treatment without systemic therapy;

Intended to be treated with anti-angiogenic targeted drugs combined with immune checkpoint inhibitors;

Disqualifiers

Usage of antibiotics within 2 weeks prior enrollment;

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

Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;

Female patients who are pregnant or breastfeeding;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral enterobacterium capsules

    Biological/Vaccine

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

  • Lenvatinib + PD-1 monoclonal antibody

    Drug

    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.

  • Oral enterobacterium capsules placebo

    Biological/Vaccine

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Experimental: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsulesExperimental treatment 2 interventions
Group B: Lenvatinib + PD-1 monoclonal antibody + Enterobacterium capsules placeboPlacebo comparator 2 interventions

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 years
2

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 years
3

Objective Objective Response Rate (ORR)

To exprole the Objective Response Rate (ORR) of patients

Time frame
Up to approximately 1 years
4

ObjectiveDuration of Response (DOR)

To analyse the Duration of Response (DOR) of patients

Time frame
Up to approximately 1 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

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: