Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06482801

Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-07-01

90

Participants Needed

1

Research Sites

602 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or/and bevacizumab through intra-tumor (IT).

CONDITIONS

Official Title

Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed cancer diagnosis by tissue testing (cytohistological confirmation)
  • Signed informed consent before joining the study
  • Age 18 years or older with expected survival longer than 3 months
  • Child-Pugh class A or B with Child score greater than 7 and ECOG score less than 2
  • Acceptable or reversible blood clotting function
  • Recent laboratory results within 7 days meeting specified blood counts and liver function levels
  • At least one measurable tumor lesion per RECIST v1.1 criteria
  • Using birth control methods
  • Willing and able to follow the treatment schedule and attend visits and tests
Not Eligible

You will not qualify if you...

  • Participation in any clinical trial with drugs or equipment in the last 4 weeks
  • Presence of ascites, hepatic encephalopathy, or bleeding from esophageal or gastric varices
  • Serious diseases affecting prognosis such as heart disease, uncontrolled diabetes, or psychiatric disorders
  • Presence of other tumors or history of other cancers
  • Pregnant or breastfeeding
  • Poor compliance with treatment or study requirements
  • Contraindications for hepatic arterial infusion including low platelet count, low prothrombin activity, renal failure requiring dialysis, severe atherosclerosis, or uncontrolled high blood pressure
  • Allergy to contrast agents
  • Use of medications affecting drug absorption or pharmacokinetics
  • Any other conditions the investigator considers unsuitable for the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China, 510260

Actively Recruiting

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Research Team

Z

Zhenfeng Zhang, MD, PhD

CONTACT

B

Bingjia He, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT | DecenTrialz