IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (… (NCT03952065) | Clinical Trial Compass
RecruitingPhase 2/3
IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)
China200 participantsStarted 2019-01-01
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Cytohistological confirmation is required for diagnosis of HNC.
✓. Signed informed consent before recruiting.
✓. Age between 18 to 80 years with estimated survival over 3 months.
✓. ECOG score \< 2
✓. Tolerable coagulation function or reversible coagulation disorders
✓. 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
✓. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
✓. Patients with advanced HNC which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection and other treatment.
Exclusion criteria
✕. Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
✕. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
✕. Patients accompanied with other tumors or past medical history of malignancy;
✕
What they're measuring
1
Overall survival
Timeframe: 2 years
Trial details
NCT IDNCT03952065
SponsorSecond Affiliated Hospital of Guangzhou Medical University