Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
NCT05187338

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-25

100

Participants Needed

1

Research Sites

730 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 advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).

CONDITIONS

Official Title

Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cytohistological confirmation of cancer diagnosis is required.
  • Signed informed consent before recruitment.
  • Age above 18 years with estimated survival over 3 months.
  • Child-Pugh class A or B/Child score > 7; ECOG score < 2.
  • Tolerable coagulation function or reversible coagulation disorders.
  • Laboratory tests within 7 days prior to procedure: WBC ≥3.0 x10^9/L; Hb ≥90 g/L; PLT ≥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 as determined by RECIST v1.1.
  • Use of birth control.
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
Not Eligible

You will not qualify if you...

  • Participation in other clinical trials of equipment or drugs within 4 weeks.
  • Presence of ascites, hepatic encephalopathy, or esophageal and gastric varices bleeding.
  • Serious accompanying diseases expected to impact prognosis, including heart disease, uncontrolled diabetes, and psychiatric disorders.
  • Presence of other tumors or past history of malignancy.
  • Pregnancy or lactation; all participants must use appropriate birth control during treatment.
  • Poor compliance.
  • Contraindications for hepatic arterial infusion: impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%), renal failure or dialysis requirement, severe atheromatosis, uncontrolled hypertension (> 160/100 mm Hg).
  • Allergy to contrast agents.
  • Use of agents affecting absorption or pharmacokinetics of study drugs.
  • Other conditions deemed unsuitable by the investigator.

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

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 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

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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