Condition or disease | Intervention/treatment | Phase |
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Head/Neck Neoplasm | Drug: PD1/PDL1 inhibitor | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein Infusion for Immunotherapy of HNC |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | January 1, 2022 |
Arm | Intervention/treatment |
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Experimental: PD1/PDL1 inhibitor infusion via neck artery
Interventional technique is used to localize neck artery to infuse the inhibitors directly into tumor.
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Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or neck artery.
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Experimental: PD1/PDL1 inhibitor infusion via peripheral vein
Routine peripheral vein infusion of PD1/PDL1 inhibitor is performed as control.
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Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or neck artery.
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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).
Contact: Hui Lian, MD | 02034153532 | lian-hui-2008@163.com | |
Contact: Zhenfeng Zhang, MD, PhD | +862039195966 | zhangzhf@gzhmu.edu.cn |
China, Guangdong | |
The Second Affiliated Hospital of Guangzhou Medical University | Recruiting |
Guanzhou, Guangdong, China, 510260 | |
Contact: Hui Lian, MD 02034153532 lian-hui-2008@163.com | |
Contact: Zhenfeng Zhang, MD, PhD +862039195966 zhangzhf@gzhmu.edu.cn |
Principal Investigator: | Hui Lian, MD | Second Affiliated Hospital of Guangzhou Medical University | |
Principal Investigator: | Zhenfeng Zhang, MD, PhD | Second Affiliated Hospital of Guangzhou Medical University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 13, 2019 | ||||||||
First Posted Date ICMJE | May 16, 2019 | ||||||||
Last Update Posted Date | April 6, 2021 | ||||||||
Actual Study Start Date ICMJE | January 1, 2019 | ||||||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: 2 years ] 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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Infusion of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein for Immunotherapy of Head/Neck Cancers (HNC) | ||||||||
Official Title ICMJE | A Phase III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1 Inhibitor Via Neck Artery Versus Vein Infusion for Immunotherapy of HNC | ||||||||
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Head/Neck Neoplasm | ||||||||
Intervention ICMJE | Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or neck artery.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
100 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 1, 2022 | ||||||||
Estimated Primary Completion Date | January 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03952065 | ||||||||
Other Study ID Numbers ICMJE | Artery PD1/PDL1 inhibitor | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Second Affiliated Hospital of Guangzhou Medical University | ||||||||
Study Sponsor ICMJE | Second Affiliated Hospital of Guangzhou Medical University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Second Affiliated Hospital of Guangzhou Medical University | ||||||||
Verification Date | April 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |