Actively Recruiting

Phase 2
Phase 3
Age: 18Years - 80Years
All Genders
NCT03952065

IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2024-06-26

200

Participants Needed

1

Research Sites

834 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer via intra-tumor or intra-artery versus vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations.

CONDITIONS

Official Title

IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cytohistological confirmation of head and neck cancer diagnosis
  • Signed informed consent before recruitment
  • Age between 18 and 80 years with expected survival over 3 months
  • ECOG performance status less than 2
  • Tolerable or reversible coagulation function disorders
  • Laboratory tests within 7 days prior: WBC ≥ 3.0 ×10^9/L; Hb ≥ 90 g/L; PLT ≥ 50 ×10^9/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 per RECIST v1.1
  • Advanced head and neck cancer unsuitable for or progressed after loco-regional therapies
  • Use of birth control
  • Willingness and ability to comply with study visits, treatment, and lab tests
Not Eligible

You will not qualify if you...

  • Participation in other clinical trials involving equipment or drugs within 4 weeks
  • Serious accompanying diseases affecting prognosis, including heart disease, uncontrolled diabetes, psychiatric disorders
  • Presence of other tumors or previous malignancies
  • Pregnancy or lactation; must use birth control during treatment
  • Poor compliance
  • Contraindications for neck artery infusion: impaired clotting (platelet count < 60000/mm3, prothrombin activity < 50%), renal failure requiring dialysis, severe atheromatosis, uncontrolled hypertension (>160/100 mmHg)
  • Allergy to adriamycin chemotherapy drugs, contrast agents, or lipiodol
  • Use of agents affecting absorption or pharmacokinetics of study drugs
  • Inability to tolerate artery infusion procedure discomfort

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

Guanzhou, Guangdong, China, 510260

Actively Recruiting

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Research Team

H

Hui Lian, MD

CONTACT

Z

Zhenfeng Zhang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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