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Compares treatment options for Head/Neck Neoplasm
Official title IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)
ClinicalTrials.gov ID: NCT03952065
What this study is testing
What is PD1/PDL1/CTLA4 inhibitors?
PD1/PDL1/CTLA4 inhibitors is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head/neck neoplasm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Patients accompanied with other tumors or past medical history of malignancy;
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Patients have poor compliance. Any contraindications for neck artery infusion procedure: A. Impaired clotting test (platelet count \ 160/100 mm/Hg).
- Allergic to adriamycin chemotherapy drugs，contrast agent or lipiodol;
See the full eligibility 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 \ 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.
- Birth control.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
- 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;
- Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
- Patients have poor compliance. Any contraindications for neck artery infusion procedure: A. Impaired clotting test (platelet count \ 160/100 mm/Hg).
- Allergic to adriamycin chemotherapy drugs，contrast agent or lipiodol;
- Any agents which could affect the absorption or pharmacokinetics of the study drugs
- people unable to suffer the discomfort of the artery infusion procedure
The study team makes the final eligibility decision.
Where it's taking place
- Guanzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guanzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.