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OncoMatch/Clinical Trials/NCT03952065

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

Is NCT03952065 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies PD1/PDL1/CTLA4 inhibitors for head/neck neoplasm.

Phase 2/3RecruitingSecond Affiliated Hospital of Guangzhou Medical UniversityNCT03952065Data as of May 2026

Treatment: PD1/PDL1/CTLA4 inhibitorsThis 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.

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Extracted eligibility criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: other clinical trials of equipment or drugs

Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks

Lab requirements

Blood counts

WBC ≥ 3.0×10E9/L; Hb ≥ 90g/L; PLT ≥ 50×10E9/L; INR < 2.3 or PT < 6 seconds above control; Platelet count < 60000/mm3, prothrombin activity < 50% [excluded]

Kidney function

Cr ≤ 145.5 umul/L; Renal failure / insufficiency requiring hemo- or peritoneal dialysis [excluded]

Liver function

Total bilirubin < 51 μmol/L; Albumin > 28 g/L

Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9/L; Hb≥90g/L; PLT ≥50×10E9/L;INR < 2.3 or PT < 6 seconds above control;Cr ≤ 145.5 umul/L;Albumin > 28 g/L;Total bilirubin < 51 μmol/L. Impaired clotting test (platelet count < 60000/mm3, prothrombin activity < 50%). Renal failure / insufficiency requiring hemo-or peritoneal dialysis. Known severe atheromatosis. Known uncontrolled blood hypertension (> 160/100 mm/Hg).

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