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2018-11-01
2033-11-01
2036-11-01
200
NCT03755739
Second Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Guangzhou Medical University
INTERVENTIONAL
Trans-Artery/Intra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors
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.
Malignant solid tumors including lung and liver cancers are the most common malignancy worldwide, and their mortality rates are very high. China has a huge population base, with about 4,000,000 new cases each year. More than 60% of the solid tumors in China are diagnosed at mid-to-late stage and have lost the chance of surgery. Recently a lot of therapeutic strategies have been developed and applied to clinic including targeted therapy and immunotherapy, but the overall efficiency is still low. It is difficult to be widely used in patients with advanced solid cancers, and more alternative therapies are urgently needed. Antibodies against PD1, PDL1 and CTLA4 are representative drugs for the check-points inhibitory agents, and their clinical indications have been approved in various types of tumors, including advanced melanoma, non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin's lymphoma and late recurrent head and neck squamous cell carcinoma patients, et al. Those drugs are regularly systemically administrated by vein infusion, however, local delivery of those drugs via interventional radiology technique including trans-artery or intra-tumor injection may increase the local drug concentration in the tumor, improve the efficacy, and reduce systemic adverse reactions, through so called ȯirst pass effect" of drug on target organs. To the investigator's knowledge, no studies have been developed on the efficacy and survival benefit of localized delivery of checkpoint inhibitors for treatment of cancer patients. This phase II-III clinical trial was designed to compare the effects of Pembrolizumab, Tecentriq, et al and/or ipilimumab plus chemotherapeutic drug such as doxorubicin on the survival benefit of patients with advanced solid cancers, including ORR, DCR, median survival time, and safety.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2018-11-03 | N/A | 2024-06-22 |
2018-11-25 | N/A | 2024-06-25 |
2018-11-28 | N/A | 2024-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Pembrolizumab via localized infusion 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 inhibi | DRUG: Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy
|
| ACTIVE_COMPARATOR: Checkpoint inhibitor (CPI) Pembrolizumab plus chemotherapy via vein infusion 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. | DRUG: Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Duration of remission (DOR) | DOR will be defined as the duration of the cancer remission | 5 years |
| Disease control rate | Disease control rate will be defined as objective response rate + steady disease rate. | 5 years |
| Cause of death (COD) when appropriate | Cause of death (COD) when appropriate | 5 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Zhenfeng Zhang, MD,PhD Phone Number: 02034153532 Email: zhangzhf@gzhmu.edu.cn |
Study Contact Backup Name: Deji Chen, MD,PhD Phone Number: 02034153532 Email: chendeji2003@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
