IT or IA Infusion of PD1/PDL1/CTLA4 Inhibitors Versus IV for Immunotherapy of Head/Neck Cancers (HNC)
A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1/CTLA4 Inhibitors or Their Combinations Via Neck Artery or Intratumor Versus Vein Infusion for Immunotherapy of HNC
Second Affiliated Hospital of Guangzhou Medical University
200 participants
Jan 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
- Birth control.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion Criteria11
- 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 \< 60000/mm3, prothrombin activity \< 50%).
- B. Renal failure / insufficiency requiring hemo-or peritoneal dialysis. C. Known severe atheromatosis. D. Known uncontrolled blood hypertension (\> 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
- Subjects unable to suffer the discomfort of the artery infusion procedure
Interventions
Infusion of PD1/PDL1/CTLA4 inhibitors through peripheral vein or neck artery/intra-tumor.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03952065