Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Cancer | Drug: PD1/PDL1 inhibitor | Phase 3 |
Liver cancer is the fifth most common malignancy worldwide, but the mortality rate ranks third. China has a large population base, with more than 400,000 new cases each year, and more than half of the world's new liver cancer and deaths. More than 70% of liver cancer patients in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Only 10%-15% of newly diagnosed patients can undergo radical resection, and the recurrence rate after 5 years is as high as 50%-80%. So far, sorafenib is still the only standard treatment that can prolong the overall survival of advanced hepatocellular carcinoma. SHARP's latest research shows that sorafenib can only extend patients with advanced liver cancer for 2.8 months, and many adverse reactions; regofenib can be used in patients with advanced liver cancer after taking sorafenib resistance, but the overall efficiency is still low. It is difficult to be widely used in patients with advanced liver cancer, and more alternative therapies are urgently needed.
PD1/PDL1 inhibitor is widely used in treatment of various cancers in China now. The hepatic arterial chemotherapy infusion for advanced liver cancer, through the "first pass effect" of drug treatment, can significantly increase the local drug concentration of the tumor, improve the efficacy, reduce systemic adverse reactions, meanwhile Folfox regimen has been confirmed by the hepatic arterial chemotherapy infusion program. To the investigator's knowledge, no studies have been developed on the survival benefit of hepatic arterial infusion of immunotherapeutic agents in patients with advanced liver cancer. 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 liver cancer, including ORR, DCR, median survival time, and safety.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 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 Hepatic Arterial Infusion Versus Vein for Immunotherapy of Advanced Liver Cancer |
Actual Study Start Date : | January 1, 2019 |
Estimated Primary Completion Date : | January 1, 2022 |
Estimated Study Completion Date : | January 2, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: PD1/PDL1 inhibitor hepatic artery infusion
Interventional technique to place microcatheter in hepatic artery to infuse PD1/PDL1 inhibitor in 30 minutes.
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Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.
Other Name: Administration of PD1/PDL1 inhibitor through vein or interventional technique.
|
Experimental: PD1/PDL1 inhibitor vein infusion
Regular IV infusion of PD1/PDL1 inhibitor in 30 minutes.
|
Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.
Other Name: Administration of PD1/PDL1 inhibitor through vein or interventional technique.
|
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 hepatic arterial 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, 51260 | |
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 | |
Sub-Investigator: Zhenfeng Zhang, MD, PHD |
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 14, 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 Hepatic Arterial Versus Vein for Immunotherapy of Advanced Hepatocellular Carcinoma | ||||||||
Official Title ICMJE | A Phase III Randomized Trial of Comparison of Survival Benefit of Administration of PD1/PDL1 Inhibitor Via Hepatic Arterial Infusion Versus Vein for Immunotherapy of Advanced Liver Cancer | ||||||||
Brief Summary | This trial was designed to investigate the survival outcomes, response rates, and safety of patients with Barcelona-Clinical Hepatocellular Carcinoma (BCLC)-C-stage liver cancer by hepatic artery versus vein infusion of PD1/PDL1 inhibitor. | ||||||||
Detailed Description |
Liver cancer is the fifth most common malignancy worldwide, but the mortality rate ranks third. China has a large population base, with more than 400,000 new cases each year, and more than half of the world's new liver cancer and deaths. More than 70% of liver cancer patients in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Only 10%-15% of newly diagnosed patients can undergo radical resection, and the recurrence rate after 5 years is as high as 50%-80%. So far, sorafenib is still the only standard treatment that can prolong the overall survival of advanced hepatocellular carcinoma. SHARP's latest research shows that sorafenib can only extend patients with advanced liver cancer for 2.8 months, and many adverse reactions; regofenib can be used in patients with advanced liver cancer after taking sorafenib resistance, but the overall efficiency is still low. It is difficult to be widely used in patients with advanced liver cancer, and more alternative therapies are urgently needed. PD1/PDL1 inhibitor is widely used in treatment of various cancers in China now. The hepatic arterial chemotherapy infusion for advanced liver cancer, through the "first pass effect" of drug treatment, can significantly increase the local drug concentration of the tumor, improve the efficacy, reduce systemic adverse reactions, meanwhile Folfox regimen has been confirmed by the hepatic arterial chemotherapy infusion program. To the investigator's knowledge, no studies have been developed on the survival benefit of hepatic arterial infusion of immunotherapeutic agents in patients with advanced liver cancer. 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 liver cancer, 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 |
||||||||
Condition ICMJE | Liver Cancer | ||||||||
Intervention ICMJE | Drug: PD1/PDL1 inhibitor
Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.
Other Name: Administration of PD1/PDL1 inhibitor through vein or interventional technique.
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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 |
200 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | January 2, 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 | NCT03949231 | ||||||||
Other Study ID Numbers ICMJE | Artery PD1/PDL1 agent for HCC | ||||||||
Has Data Monitoring Committee | No | ||||||||
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 | November 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |