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Recruiting NCT03952065

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

Phase II / Phase III Interventional Head/Neck Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PD1/PDL1/CTLA4 inhibitors.
Who it may be relevant to
Registry conditions: Head/Neck Neoplasm. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Head/Neck cancer is a kind of hard-to-treat malignancy worldwide and its overall survival rate is still low. PD1/PDL1/CTLA4 inhibitors are widely used to treat various of cancers now. Delivery of antibody drugs through interventional approaches including intra-tumor or intra-artery, based on the theory of "first pass effect" of drug, can significantly increase the local drug concentration of the tumor, improve the efficacy, and reduce systemic adverse reactions.

To the investigator's knowledge, no studies have been developed on the survival benefit of neck artery infusion or intra-tumor injection of immunotherapeutic agents in patients with advanced HNC. This phase II-III clinical trial was designed to compare the effects of PD1/PDL1/CTLA4 inhibitor or their combinations via IA/IT and IV on the survival benefit of patients with advanced HNC, including ORR, DCR, median survival time, and safety.

Interventions

  • Drug PD1/PDL1/CTLA4 inhibitors
    Infusion of PD1/PDL1/CTLA4 inhibitors through peripheral vein or neck artery/intra-tumor.

Primary outcome measures

  • Overall survival [Time frame: 2 years]
Secondary outcome measures (2)
  • Progression-free survival [Time frame: 2 years]
  • Adverse event rate [Time frame: 2 years]

Eligibility criteria

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.
  • Birth control.
  • Willing and able to comply with scheduled visits, treatment plan and laboratory tests.

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;
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Second Affiliated Hospital of Guangzhou Medical University — Guanzhou

Identifiers

NCT: NCT03952065 · ZZITICI-009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗