Unresectable Pancreatic CancerNCT01665625
Regional Versus Systemic Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
A study testing regional interventional chemotherapy group in people with Unresectable Pancreatic Cancer, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Unresectable Pancreatic Cancer
- What is being tested?
- regional interventional chemotherapy group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2012to Feb 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent
- Karnofsky score > 60,
- Expected survival > 3 months,
- Liver, kidney function and routine blood test within normal range
- No serious cardiopulmonary dysfunction
- No acute infection
Who cannot join
- Pregnant or lactating women
- Uncontrolled internal diseases
- Past or the presence of other malignancy
- Those who had received immunosuppressive therapy
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
GuoHong Han, MD, 86-29-84775221, hangh@fmmu.edu.cn
Jun Tie, PH.D.,MD
About this study
Official title: A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.
- Conditions
- Unresectable Pancreatic Cancer
- Being tested
- regional interventional chemotherapy group
- Keywords
- Pancreatic cancer, Intra-arterial infusion, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional interventional chemotherapy groupProcedure or surgery
The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
| Study group | Role | What they receive |
|---|---|---|
| regional interventional chemotherapy group | Experimental | Not described Receives: Procedure: regional interventional chemotherapy group |
| systemic chemotherapy | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall surviva
Measured: 36 months
Secondary outcomes (4)
Clinical Benefit Rate
Measured: 12 months
The median progression-free survival PFS
Measured: 12 months
Drug Toxicity
The grading standards of the World Health Organization for acute and subacute toxicity of anticancer drugs will be used to grade toxicity.
Measured: 18 months
surgical complications
Major surgical complications included allergic reaction to the contrast agent, local hematoma, pneumothorax, puncture site bleeding, wound infection, delayed healing or cracking, port-catheter blockage, and necrosis of the tissue surrounding the port-catheter.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
- Investigators
- Guohong Han, MD, Principal investigator, Xijing Hospital of Digestive Diseases, Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665625
- Sponsor's protocol ID
- XHDD 003
- Status last verified
- Aug 2012
- First submitted
- 15 Jul 2012
- Last updated
- 15 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.
PubMed 16412037
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial of Regional Versus Systemic Continuous Gemcitabine Chemotherapy in the Treatment of Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01665625
- Acronym / sponsor ID
- XHDD 003
- Conditions
- Unresectable Pancreatic Cancer
- Keywords
- Pancreatic cancer, Intra-arterial infusion, Gemcitabine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 15 Aug 2012 (estimated)
- 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.
Systemic chemotherapy with cytotoxic drug is of limited effectiveness in advanced pancreatic cancer patients. Gemcitabine has been used as the first-line drug for advance pancreatic cancer for over two decades and combinations of gemcitabine with different chemotherapeutic drugs have been investigated to improve the outcomes of pancreatic cancer. However, no substantial improvement in patient survival has been achieved. Locoregional chemotherapy via intra-arterial perfusion or chemoemoblization takes advantage of the increasing local drug concentrations and reducing systemic toxicities. In this study, the investigators hypothesis that artery infusion chemotherapy had a better antitumor effect than systemic chemotherapy. The investigators will analyze and evaluate the effect and safety of an implanted percutaneous left subclavian artery port-catheter drug delivery system for regional chemotherapy of inoperable pancreatic carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional interventional chemotherapy group | Experimental | Procedure: regional interventional chemotherapy group |
| systemic chemotherapy | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed written informed consent
- Karnofsky score > 60,
- Expected survival > 3 months,
- Liver, kidney function and routine blood test within normal range
- No serious cardiopulmonary dysfunction
Key exclusion criteria (4 listed)
- Pregnant or lactating women
- Uncontrolled internal diseases
- Past or the presence of other malignancy
- Those who had received immunosuppressive therapy
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 |
|---|---|---|
| regional interventional chemotherapy groupThe patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest. | Procedure or surgery | regional interventional chemotherapy group |
Primary outcome
overall surviva
Time frame: 36 months
4 secondary outcomes
Clinical Benefit Rate
Time frame: 12 months
The median progression-free survival PFS
Time frame: 12 months
Drug Toxicity
Time frame: 18 months
surgical complications
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2012.
- Background: PubMed 16412037Han GH, Yin ZX, Meng XJ, He CY, Zhang HB, Sun AH, Wu KC, Ding J, Fan DM. Prospective randomized clinical trial of two drug delivery pathway in the treatment of inoperable advanced pancreatic carcinoma. Chin J Dig Dis. 2006;7(1):45-8. doi: 10.1111/j.1443-9573.2006.00243.x.
Related trials for Unresectable Pancreatic Cancer
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
RecruitingPhase 2
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Solid Tumors, HER2 Mutation
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
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.
Guohong Han, MD principal investigator
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing regional interventional chemotherapy group in people with Unresectable Pancreatic Cancer, run by Air Force Military Medical University, China at 2 sites 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 6 inclusion and 4 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 15 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Jun Tie, PH.D., MD (+86-29-84771528, tiejun7776@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall surviva (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01665625, which also lists 1 linked publication.
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 15 Aug 2012.