Pancreatic Ductal AdenocarcinomaNCT03687853
Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
A study testing Intrahepatic Arterial Infusion in people with Pancreatic Ductal Adenocarcinoma and Who Have High CTCs Count in Portal Venous Blood, run by Peking University Third Hospital at 1 site in China.
Trial summary
Clinical results on intra-arterial adjuvant chemotherapy for prevention of liver metastasis following curative resection of pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma, Who Have High CTCs Count in Portal Venous Blood, Liver Metastases
- What is being tested?
- Intrahepatic Arterial Infusion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pancreatic cancer patients who received the radical operation
Who cannot join
- who accepted chemotherapy before operation or who cannot or do not will to accepted enrolled into this study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of General Surgery,Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Clinical results on intra-arterial adjuvant chemotherapy for prevention
of liver metastasis following curative resection of pancreatic cancer
Read the detailed description
In this study, the investigator try to select 80 patients who received radical surgery for pancreatic cancer, whose circulating tumor cells(CTCs) count then performed on intraoperative portal venous blood to predict postoperative liver metastasis and were divided into two groups. for those who have high CTCs count may have more chance for the occurrence of postoperative liver metastasis was applied hepatic arterial perfusion chemotherapy with minimal dynamic randomization. The aim is to evaluate the feasibility of hepatic arterial infusion chemotherapy for the prevention of postoperative liver metastasis and improvement of prognosis of pancreatic cancer, so as to further improve postoperative management of pancreatic cancer
- Conditions
- Pancreatic Ductal Adenocarcinoma, Who Have High CTCs Count in Portal Venous Blood, Liver Metastases
- Being tested
- Intrahepatic Arterial Infusion
- Keywords
- Pancreatic ductal adenocarcinoma, arterial infusion chemotherapy, liver metastases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrahepatic Arterial InfusionDevice
Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.
| Study group | Role | What they receive |
|---|---|---|
| Intrahepatic Arterial Infusion chemotherapy | Experimental | chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments. Receives: Device: Intrahepatic Arterial Infusion |
| control | No intervention | chemotherapy through Peripheral venous is one of the regularly used method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Overall survival time after operation
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pancreatic cancer patients who received hepatic arterial perfusion chemotherapy after operation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- dianrong xiu, doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687853
- Sponsor's protocol ID
- HAI PDCA 1.0
- Status last verified
- Sep 2018
- First submitted
- 20 Aug 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery
- ClinicalTrials.gov ID
- NCT03687853
- Acronym / sponsor ID
- HAI PDCA 1.0
- Conditions
- Pancreatic Ductal Adenocarcinoma, Who Have High CTCs Count in Portal Venous Blood, Liver Metastases
- Keywords
- Pancreatic ductal adenocarcinoma, arterial infusion chemotherapy, liver metastases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical results on intra-arterial adjuvant chemotherapy for prevention
of liver metastasis following curative resection of pancreatic cancer
Detailed description
In this study, the investigator try to select 80 patients who received radical surgery for pancreatic cancer, whose circulating tumor cells(CTCs) count then performed on intraoperative portal venous blood to predict postoperative liver metastasis and were divided into two groups. for those who have high CTCs count may have more chance for the occurrence of postoperative liver metastasis was applied hepatic arterial perfusion chemotherapy with minimal dynamic randomization. The aim is to evaluate the feasibility of hepatic arterial infusion chemotherapy for the prevention of postoperative liver metastasis and improvement of prognosis of pancreatic cancer, so as to further improve postoperative management of pancreatic cancer
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pancreatic cancer patients who received hepatic arterial perfusion chemotherapy after operation
| Arm | Type | Receives |
|---|---|---|
| Intrahepatic Arterial Infusion chemotherapy | Experimental | Device: Intrahepatic Arterial Infusionchemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments. |
| control | No intervention | –chemotherapy through Peripheral venous is one of the regularly used method. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pancreatic cancer patients who received the radical operation
Key exclusion criteria (1 listed)
- who accepted chemotherapy before operation or who cannot or do not will to accepted enrolled into this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrahepatic Arterial InfusionIntrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments. | Device | Intrahepatic Arterial Infusion chemotherapy |
Primary outcome
Death
Time frame: up to 12 months
Overall survival time after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dianrong xiu, doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrahepatic Arterial Infusion in people with Pancreatic Ductal Adenocarcinoma and Who Have High CTCs Count in Portal Venous Blood, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.