A Phase II/III Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of Advanced Solid Tumors
Sponsor study identifier
interventional
200
1 country
1
Study Start
November 1, 2018
Actual (reported)Primary Completion
November 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery/intra-tumor infusion of PD1/PDL1 antibody and/or CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2018
Actual (reported)November 3, 2018
Actual (reported)November 28, 2018
Actual (reported)November 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2036
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.
5 years
Complete response (CR) rate before or at Month 6
Percentage of patients achieving complete response (CR) before or at Month 6
4
Progression-free survival
5 years
This group dividied into two subgroups: 1. Checkpoint inhibitor (CPI) such as Pembrolizumab ± Ipilimumab is administrated with a dose of 1-2mg/kg via sustained (10min) micro-pump infusion via artery, plus chemotherapy, every 3 weeks. 2. Checkpoint inhibitor (CPI) such as Pembrolizumab ± Ipilimumab is administrated with a total dose of 150mg via intra-tumor fine needle injection in 5 min, plus doxorubicin, every 3 weeks.
Checkpoint inhibitor (CPI) such as Pembrolizumab is administrated with a total dose of 2mg/kg via vein infusion (30 min), plus chemotherpy every 3 weeks.
vein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and/or Ipilimumab, plus chemotherapy to destroy cancer cells and release tumor antigen for improving CPI therapeutic efficacy.
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, 51260, 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.
Tan H, Shah NUH, He B, Liu T, Li T, Liu M, Gu Y, Zhi C, Ou Y, Huang J, Li M, Zuo S, Chen D, Qin R, Yang H, Li X, Lian H, Wu Q, Leidner R, Chen R, Yang A, Yang L, Zhang Z. Intratumoral delivery of PD-1/PD-L1 and CTLA-4 inhibitors for recurrent/refractory solid tumors: a proof-of-concept treatment strategy. Front Immunol. 2025 Dec 12;16:1669924. doi: 10.3389/fimmu.2025.1669924. eCollection 2025.
Zhenfeng Zhang, MD,PhD
Second Affiliated Hospital of Guangzhou Medical University
First Submitted
November 3, 2018
First Posted
November 28, 2018
Study Start
November 1, 2018
Actual (reported)Primary Completion
November 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
Duration of remission (DOR)
5 years
Disease control rate
5 years
Cause of death (COD) when appropriate
5
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Study Completion
November 1, 2036
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 25, 2024
Record last verified: 2024-06
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Source: ClinicalTrials.gov.
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