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
Sponsor study identifier
interventional
200
1 country
1
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2019
Actual (reported)May 13, 2019
Actual (reported)May 16, 2019
Actual (reported)January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
2 years
Progression-free survival
2 years
Adverse event rate
2 years
Interventional technique is used to localize neck artery to infuse the inhibitor or their combinations directly into tumor.
Routine peripheral vein infusion of PD1/PDL1/CTLA4 inhibitor or their combinations is performed.
Infusion of PD1/PDL1/CTLA4 inhibitors through peripheral vein or neck artery/intra-tumor.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Second Affiliated Hospital of Guangzhou Medical University
Guanzhou, Guangdong, 510260, China
Ou Y, Zhang J, Tan H, He B, Li T, Liu M, Zhi C, Huang J, Li M, Zuo S, Shah NUH, Chen Y, Huang J, Chen D, Qin R, Li X, Lian H, Wu Q, Yang H, Zhang Z. CT-guided intratumoral immunotherapy for advanced solid tumors: a prospective clinical study of safety and systemic antitumor effects. Front Immunol. 2026 Jul 24;17:1869154. doi: 10.3389/fimmu.2026.1869154. eCollection 2026.
Hui Lian, MD
Second Affiliated Hospital of Guangzhou Medical University
Zhenfeng Zhang, MD, PhD
Second Affiliated Hospital of Guangzhou Medical University
First Submitted
May 13, 2019
First Posted
May 16, 2019
Study Start
January 1, 2019
Actual (reported)Primary Completion
January 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Interventional technique is used to intra-tumor injection of the inhibitor or their combinations directly into tumor.
Contact the study team to confirm eligibility.
Study Completion
January 1, 2035
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 26, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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