Carcinoma, PancreaticPhase 2NCT02635971
Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer
A Phase 2 study testing Transcatheter arterial infusion, Intravenous chemotherapy and Gemcitabine in people with Carcinoma, Pancreatic, run by Fudan University at 1 site in China.
Trial summary
This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Pancreatic
- What is being tested?
- Transcatheter arterial infusion, Intravenous chemotherapy and Gemcitabine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2022
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
- Measurable disease by RECIST criteria must be present.
- Karnofsky Performance Status ≥ 70
- Patients with adequate organ functions reflected by the laboratory criteria below:
- Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal
- Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
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- Patients with jaundice must have a biliary drainage decompression operation before recruitment.
- Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
- Ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Subject with metastatic disease.
- Prior treatment with systemic chemotherapy.
- Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
- Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
- Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
- Concurrent infection requiring intravenous antibiotics.
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- Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
- Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
- Known central nervous system involvement and leptomeningeal disease
- Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yehua Shen, MD, Ph D, 86-21-64175590 ext. 83625, yehuash25@163.com
Zhiqiang Meng, MD, Ph D
About this study
Official title: A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer
This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).
Read the detailed description
Primary Outcome Measures:
To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.
Secondary Outcome Measures:
To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.
Exploratory Outcome Measures:
To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.
- Conditions
- Carcinoma, Pancreatic
- Being tested
- Transcatheter arterial infusion, Intravenous chemotherapy, Gemcitabine, Oxaliplatin
- Keywords
- transcatheter arterial infusion, randomized controlled trial, chemotherapy
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter arterial infusionProcedure or surgery
Intravenous chemotherapyProcedure or surgery
GemcitabineDrug
OxaliplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| TAI chemotherapy | Experimental | Patients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. Receives: Procedure: Transcatheter arterial infusion; Drug: Gemcitabine; Drug: Oxaliplatin |
| Chemotherapy | Active comparator | Patients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. Receives: Procedure: Intravenous chemotherapy; Drug: Gemcitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From date of randomization until the date of death, assessed up to 100 months.
Secondary outcomes (1)
Progression free survival
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (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 Carcinoma, PancreaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiqiang Meng, Fudan University
- Investigators
- Zhiqiang Meng, MD, Ph D, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635971
- Sponsor's protocol ID
- TAI-2015
- Status last verified
- Mar 2020
- First submitted
- 17 Dec 2015
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Huang C, Cheng CS, Shen Y, Chen H, Lin J, Hua Y, Feng L, Wu C, Wang P, Chen Z, Meng Z. Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy. BMC Cancer. 2024 Aug 2;24(1):941. doi: 10.1186/s12885-024-12695-8.
PubMed 39095759
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase II Study on Intra-arterial Versus Intravenous Chemotherapy Infusion With Gemcitabine and Oxaliplatin for Locally Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT02635971
- Acronym / sponsor ID
- TAI-2015
- Conditions
- Carcinoma, Pancreatic
- Keywords
- transcatheter arterial infusion, randomized controlled trial, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 21 Dec 2015 (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.
This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).
Detailed description
Primary Outcome Measures:
To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.
Secondary Outcome Measures:
To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.
Exploratory Outcome Measures:
To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAI chemotherapy | Experimental | Procedure: Transcatheter arterial infusion, Drug: Gemcitabine, Drug: OxaliplatinPatients in this arm will receive transcatheter arterial infusion of chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. |
| Chemotherapy | Active comparator | Procedure: Intravenous chemotherapy, Drug: Gemcitabine, Drug: OxaliplatinPatients in this arm will receive intravenous chemotherapy with gemcitabine and oxaliplatin every 2 weeks, until progression of disease or adverse effects leading to treatment termination. Each 4-week period is one cycle of treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
- Measurable disease by RECIST criteria must be present.
- Karnofsky Performance Status ≥ 70
- Patients with adequate organ functions reflected by the laboratory criteria below:
- Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine < 2.0 mg/dL Bilirubin < 1.5 mg/dL SGPT < 2.5 x normal Alk Phos < 2.5 x normal
Key exclusion criteria (11 listed)
- Subject with metastatic disease.
- Prior treatment with systemic chemotherapy.
- Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
- Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
- Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
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 |
|---|---|---|
| Transcatheter arterial infusion | Procedure or surgery | TAI chemotherapy |
| Intravenous chemotherapy | Procedure or surgery | Chemotherapy |
| Gemcitabine | Drug | Chemotherapy, TAI chemotherapy |
| Oxaliplatin | Drug | Chemotherapy, TAI chemotherapy |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of death, assessed up to 100 months.
1 secondary outcome
Progression free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 39095759Huang C, Cheng CS, Shen Y, Chen H, Lin J, Hua Y, Feng L, Wu C, Wang P, Chen Z, Meng Z. Digital subtraction angiography-guided pancreatic arterial infusion of GEMOX chemotherapy in advanced pancreatic adenocarcinoma: a phase II, open-label, randomized controlled trial comparing with intravenous chemotherapy. BMC Cancer. 2024 Aug 2;24(1):941. doi: 10.1186/s12885-024-12695-8.
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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.
Zhiqiang Meng, MD, Ph D principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcatheter arterial infusion, Intravenous chemotherapy and Gemcitabine in people with Carcinoma, Pancreatic, run by Fudan University 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 9 inclusion and 11 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 5 Mar 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yehua Shen, MD, Ph D (86-21-64175590 ext. 83625, yehuash25@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization until the date of death, assessed up to 100 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 NCT02635971, 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 5 Mar 2020.