Infusion methods for immunotherapy in head and neck cancers

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

This study is testing whether delivering immunotherapy directly into head and neck tumors or arteries can help advanced cancer patients live longer and feel better compared to the usual IV method.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT03952065 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the survival outcomes, response rates, and safety of advanced Head/Neck Squamous cancer patients receiving PD1/PDL1/CTLA4 inhibitors through intra-tumor or intra-artery infusion compared to traditional intravenous methods. The study aims to enhance local drug concentration at the tumor site, potentially improving efficacy while minimizing systemic side effects. It is a phase II-III trial designed to evaluate the benefits of these innovative delivery methods on patient survival and overall response rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed advanced head and neck cancer who have not responded to previous local therapies.

Not a fit: Patients with early-stage head and neck cancer or those who are currently participating in other clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve survival rates and treatment outcomes for patients with advanced head and neck cancers.

How similar studies have performed: While the use of PD1/PDL1/CTLA4 inhibitors is established, the specific infusion methods being tested in this trial are novel and have not been previously studied in this context.

Eligibility criteria

Inclusion Criteria:

1. Cytohistological confirmation is required for diagnosis of HNC.
2. Signed informed consent before recruiting.
3. Age between 18 to 80 years with estimated survival over 3 months.
4. ECOG score \< 2
5. Tolerable coagulation function or reversible coagulation disorders
6. 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
7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
8. 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.
9. Birth control.
10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

Exclusion Criteria:

1. Patients participated in other clinical trials of equipment or drugs (signed informed consent) within 4 weeks;
2. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;
3. Patients accompanied with other tumors or past medical history of malignancy;
4. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;
5. 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).
6. Allergic to adriamycin chemotherapy drugs，contrast agent or lipiodol;
7. Any agents which could affect the absorption or pharmacokinetics of the study drugs
8. Subjects unable to suffer the discomfort of the artery infusion procedure

Where this trial is running

Guanzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Hui Lian, MD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Hui Lian, MD

Conditions: Head/Neck Neoplasm, Head/Neck tumor, PD1 antibody, Artery infusion, PDL1 antibody, CTLA4 antibody, Intra-tumor, Interventional therapy