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Infusion of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC)

Primary Purpose

Head/Neck Neoplasm

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

PD1/PDL1 inhibitor

About this trial

This is an interventional treatment trial for Head/Neck Neoplasm focused on measuring Head/Neck tumor, PD1 antibody, Artery infusion, PDL1 antibody

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Second Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PD1/PDL1 inhibitor infusion via neck artery

PD1/PDL1 inhibitor infusion via peripheral vein

Arm Description

Interventional technique is used to localize neck artery to infuse the inhibitors directly into tumor.

Routine peripheral vein infusion of PD1/PDL1 inhibitor is performed as control.

Outcomes

Primary Outcome Measures

Overall survival

Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive). Follow-up for OS will occur every 12 weeks (±1 month) until death or withdrawal of consent from the study.

Secondary Outcome Measures

Progression-free survival

Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per mRECIST) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment.

Adverse event rate

Adverse event rate will be defined as the rate of patients who developed adverse event.

Full Information

NCT ID

NCT03952065

First Posted

May 13, 2019

Last Updated

February 26, 2023

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03952065

Brief Title

Infusion of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC)

Official Title

A Phase II/III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein Infusion for Immunotherapy of HNC

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

January 1, 2025 (Anticipated)

Study Completion Date

January 1, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital of Guangzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This trial was designed to investigate the survival outcomes, response rates, and safety of patients with advanced Head/Neck Squamous cancer by neck artery versus vein infusion of PD1/PDL1 inhibitor.

Detailed Description

Head/Neck cancer is a kind of hard-to-treat malignancy worldwide and its overall survival rate is still low. PD1/PDL1 inhibitor are widely used to treat various of cancers in China now. The neck arterial chemotherapy infusion for advanced HNC, through the "first pass effect" of drug treatment, 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 of immunotherapeutic agents in patients with advanced HNC. This phase III clinical trial was designed to compare the effects of PD1/PDL1 inhibitor via IA and IV on the survival benefit of patients with advanced HNC, including ORR, DCR, median survival time, and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head/Neck Neoplasm

Keywords

Head/Neck tumor, PD1 antibody, Artery infusion, PDL1 antibody

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD1/PDL1 inhibitor infusion via neck artery

Arm Type

Experimental

Arm Description

Interventional technique is used to localize neck artery to infuse the inhibitors directly into tumor.

Arm Title

PD1/PDL1 inhibitor infusion via peripheral vein

Arm Type

Experimental

Arm Description

Routine peripheral vein infusion of PD1/PDL1 inhibitor is performed as control.

Intervention Type

Drug

Intervention Name(s)

PD1/PDL1 inhibitor

Intervention Description

Infusion of PD1/PDL1 inhibitor through peripheral vein or neck artery.

Primary Outcome Measure Information:

Title

Overall survival

Description

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Time Frame

2 years

Title

Adverse event rate

Description

Adverse event rate will be defined as the rate of patients who developed adverse event.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hui Lian, MD

Phone

02034153532

lian-hui-2008@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhenfeng Zhang, MD, PhD

Phone

+862039195966

zhangzhf@gzhmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui Lian, MD

Organizational Affiliation

Second Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Zhenfeng Zhang, MD, PhD

Organizational Affiliation

Second Affiliated Hospital of Guangzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second Affiliated Hospital of Guangzhou Medical University

City

Guanzhou

State/Province

Guangdong

ZIP/Postal Code

510260

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hui Lian, MD

Phone

02034153532

lian-hui-2008@163.com

First Name & Middle Initial & Last Name & Degree

Zhenfeng Zhang, MD, PhD

Phone

+862039195966

zhangzhf@gzhmu.edu.cn

12. IPD Sharing Statement

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Infusion of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC)

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