Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06483347

Checkpoint Inhibitor Combinations Therapy as First Line for Inoperable Lung Cancer Via IT

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-07-03

90

Participants Needed

1

Research Sites

508 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 inoperable lung cancer 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 Inoperable Lung Cancer Via IT

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cytohistological confirmation of lung cancer diagnosis
  • Signed informed consent before joining the study
  • Age above 18 years with estimated survival over 3 months
  • Child-Pugh class A or B with a score greater than 7; ECOG score less than 2
  • Tolerable or reversible coagulation function disorders
  • Laboratory tests within 7 days before treatment showing: WBC ≥ 3.0 x10^9/L; Hemoglobin ≥ 90 g/L; Platelets ≥ 50 x10^9/L; INR < 2.3 or PT < 6 seconds above control; Creatinine ≤ 145.5 umol/L; Albumin > 28 g/L; Total bilirubin < 51 µmol/L
  • At least one measurable tumor lesion based on RECIST v1.1 criteria
  • Use of birth control during the study
  • Willingness and ability to comply with scheduled visits, treatment plan, and lab tests
Not Eligible

You will not qualify if you...

  • Participation in other clinical trials of drugs or equipment within the past 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 or history of other tumors or cancers
  • Pregnancy or lactation without appropriate birth control
  • Poor compliance with study requirements
  • Contraindications to hepatic arterial infusion including impaired clotting (platelets < 60000/mm3, prothrombin activity < 50%), renal failure requiring dialysis, severe atheromatosis, or uncontrolled high blood pressure (>160/100 mmHg)
  • Allergy to contrast agents
  • Use of agents affecting absorption or pharmacokinetics of study drugs
  • Any other condition the investigator deems 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, Guangdong, China

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 Inoperable Lung Cancer Via IT | DecenTrialz