New combo therapy aims to tackle tough pancreatic tumors
NCT ID NCT02207465
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 1 trial tests a combination of radiation therapy and the chemotherapy drug Abraxane (nab-paclitaxel) in people with pancreatic cancer that cannot be surgically removed. The goal is to find the safest and most effective doses to improve local tumor control and survival. The study involves 42 participants and will also explore adding another drug, paricalcitol, in some cases.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Abraxane (nab-paclitaxel) combined with radiation therapy
- What this could lead to
- If successful, this could lead to a more effective treatment option for people with pancreatic cancer that cannot be removed by surgery, potentially improving local tumor control and survival.
- What could go wrong
- This is an early phase 1 trial with only 42 participants, so results may not apply to everyone. The main goal is to find safe doses, not to prove effectiveness. Side effects from the combination of chemotherapy and radiation are expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Jul 2014
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically confirmed adenocarcinoma of the pancreas. * Unresectable disease or borderline resectable disease assessed by a multidisciplinary panel of pancreas surgeon, medical and radiation oncologist, and a radiologist. Criteria defining unresectable and borderline resectable patients will be based on the NCCN Guidelines (v 1.2014): Unresectable * Greater than 180 degrees of SMA encasement * Any celiac abutment * Unreconstructible SMV/portal occlusion * Aortic invasion or encasement * Nodal metastases beyond the field of resection Borderline resectable * Venous involvement of the SMV/portal vein demonstrating tumor abutment with impingement and narrowing of the lumen * Encasement of the SMV/portal vein but without encasement of the nearby arteries * Short-segment venous occlusion resulting from either tumor thrombus or encasement with suitable proximal and distal vessel for reconstruction/grafting. * Gastroduodenal artery encasement up to the hepatic artery with either short segment encasement or direct abutment of the hepatic artery, without extension to celiac axis * Tumor abutment to SMA but not to exceed greater than 180 degrees of circumferential vessel wall * Age \> 18 years. * ECOG performance status of ≤ 1. * Adequate organ function defined as follows: absolute neutrophil count of ≥ 1500/mm3, platelets ≥ 100,000/mm3, serum creatinine ≤ 2 mg/dl, total bilirubin ≤ 3, (with relief of biliary obstruction if present (PTC tube or endobiliary stent) and AST \< 5 times the upper limit of normal. * Patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after the trial. * Patients must be able to provide written informed consent. Exclusion Criteria: * Distant metastatic disease. * Prior history of abdominal radiation therapy. * Prior systemic therapy for pancreatic cancer. * Prior or simultaneous malignancy within the past 2 years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ, thyroid carcinoma, or low-risk prostate cancer). In-situ carcinoma is allowed. * Serious uncontrolled concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy. * Treatment with an investigational anti-cancer agent within 4 weeks prior to enrollment into the study. * Pregnant women, women planning to become pregnant and women that are nursing
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Chester County Hospital
West Chester, Pennsylvania, 19380, United States
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Other studies related to the condition(s) this trial covers.
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