Pancreatic CancerPhase 2NCT07871461
Utilizing Standard of Care Induction Chemotherapy Followed by MR-LINAC Radiotherapy and Surgical Exploration to Improve Resectability Rates in Potentially Resectable Locally Advanced Pancreatic Cancer
A Phase 2 study testing Induction Chemotherapy - FOLFIRINOX, Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel and MR-LINAC Guided Radiotherapy in people with Pancreatic Cancer, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
Locally advanced pancreatic cancer (LAPC) is a high-mortality condition. This single-institution, Phase II, single-arm investigator-initiated trial at Allegheny Health Network investigates the optimal timing and integration of established standard-of-care interventions for biopsy-proven LAPC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Induction Chemotherapy - FOLFIRINOX, Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel and MR-LINAC Guided Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2028
- Phase
- Phase 2
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients age 18 or older.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Locally advanced, potentially resectable disease per ABC criteria after multidisciplinary review:
- Anatomic: Tumor-artery contact >180° but <270° with the SMA or celiac, or ≤180° with mild contour irregularity but no frank stenosis; common hepatic artery (CHA) contact not reaching the celiac axis; venous involvement with a reconstructable SMV-PV segment.
- Biologic: CA19-9 < 600 U/mL (after biliary drainage if obstructed) and no evidence of radiographic/biochemical progression at baseline.
- Conditional: ECOG 0-1, comorbidities optimized, albumin ≥ 3.0 g/dL.
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- No evidence of metastatic disease on staging imaging and laparoscopy.
- Measurable or evaluable disease on pancreas-protocol CT or MRI (RECIST v1.1).
- Adequate organ function, including all of the following (local lab ULN applied):
- ANC ≥ 1.5 × 10⁹/L; platelets ≥ 100 × 10⁹/L; hemoglobin ≥ 9 g/dL.
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if adequately stented); AST/ALT ≤ 2.5 × ULN.
- Creatinine clearance ≥ 50 mL/min (Cockcroft-Gault or equivalent).
- ASA physical status I-III.
- Life expectancy ≥ 12 weeks.
- Able and willing to comply with study visits/procedures
- Informed consent obtained; HIPAA authorization per institutional policy.
- For participants of childbearing potential: negative pregnancy test at screening and agreement to use effective contraception during protocol therapy and the specified post-therapy interval.
Who cannot join
- Patients age < 18 or ≥ 90 years.
- Metastatic disease on staging (distant organ or peritoneal metastases).
- Disease meeting non-operative/unresectable ABC criteria, including any of the following:
- Anatomic: SMA encasement ≥ 270°; CHA involvement to the celiac origin/trifurcation; aortic invasion; no reconstructable SMV-PV segment; IVC invasion.
- Biologic: CA19-9 ≥ 600 U/mL (after biliary drainage if obstructed) or clear radiographic/biochemical progression prior to starting protocol therapy.
- Conditional: ECOG ≥ 2, ASA ≥ IV, or comorbidities that preclude major abdominal surgery despite optimization.
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- Prior radiotherapy to the pancreas or overlapping abdominal fields that would preclude protocol RT.
- Prior pancreatic resection or local ablative therapy (e.g., IRE/RFA) to the primary tumor.
- Prior systemic therapy for current LAPC (neoadjuvant/induction) before consent/enrollment.
- Uncontrolled biliary obstruction not amenable to adequate drainage.
- Active, uncontrolled infection or clinically significant cardiac, pulmonary, or hepatic disease that, in the investigator's judgment, poses unacceptable risk.
- Contraindications to MRI/MR-guided therapy (e.g., non-MRI-compatible implants) or severe claustrophobia not manageable with standard measures.
- Pregnant or breastfeeding individuals.
- Known hypersensitivity to intended study medications or essential components of supportive care that cannot be mitigated.
- Concurrent malignancy requiring active systemic treatment (except adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- Inability to provide informed consent or to comply with study procedures/assessments; absence of a legally authorized representative when needed.
- Concurrent enrollment in another interventional clinical trial that, in the opinion of the investigator, could interfere with outcomes of this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
AHN Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Clinical Trials Contact, 412-330-6151, ctgov@ahn.org
About this study
Locally advanced pancreatic cancer (LAPC) is a high-mortality condition. This single-institution, Phase II, single-arm investigator-initiated trial at Allegheny Health Network investigates the optimal timing and integration of established standard-of-care interventions for biopsy-proven LAPC. Eligible participants will receive standard 4 months of induction chemotherapy, followed by standard MR-LINAC-guided radiotherapy, and subsequent surgical exploration with curative intent where feasible. The research question specifically pertains to the efficacy and safety of this predefined treatment sequence, aiming to increase the proportion of LAPC patients who achieve R0 resection and to translate local control gains into better survival and quality of life. The study plans to accrue approximately 18-20 patients.
- Conditions
- Pancreatic Cancer
- Being tested
- Induction Chemotherapy - FOLFIRINOX, Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel, MR-LINAC Guided Radiotherapy, Surgical Exploration and Resection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction Chemotherapy - FOLFIRINOXDrug
Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.
Induction Chemotherapy - Gemcitabine and Nab-PaclitaxelDrug
Participants will receive approximately 4 months of systemic chemotherapy to treat micrometastatic disease and potentially downstage the tumor. The specific regimen will be either FOLFIRINOX (folinic acid, fluorouracil, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel, chosen by the investigator according to NCCN guidelines and institutional standards. This phase aims to optimize tumor biology prior to local consolidation therapy and subsequent surgery.
MR-LINAC Guided RadiotherapyRadiation
Following induction chemotherapy, eligible participants will undergo hypofractionated radiotherapy utilizing an MR-LINAC (Magnetic Resonance-Linear Accelerator) system. This advanced image-guided radiation therapy allows for daily adaptive planning and real-time soft-tissue visualization to precisely target the pancreatic tumor while minimizing radiation exposure to surrounding healthy organs. This intervention serves as local consolidation therapy to improve local control and increase the likelihood of successful surgical resection.
Surgical Exploration and ResectionProcedure or surgery
Approximately 4-8 weeks after completing MR-LINAC guided radiotherapy, participants will undergo surgical exploration with curative intent. The primary goal is to achieve a margin-negative (R0) resection of the pancreatic tumor, which is a key predictor of long-term survival. This may involve complex procedures such as venous resection/reconstruction and arterial divestment if deemed feasible and beneficial by the surgeon, following institutional standards and risk-benefit assessment.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-Care Sequential Therapy | Experimental | Participants will receive a predefined sequence of established standard-of-care treatments for locally advanced pancreatic cancer (LAPC). This sequence includes approximately 4 months of induction chemotherapy (FOLFIRINOX or gemcitabine/nab-paclitaxel, per investigator's choice), followed by MR-LINAC guided radiotherapy, and subsequent surgical exploration with curative intent when feasible. Follow-up will continue for up to 5 years. Receives: Drug: Induction Chemotherapy - FOLFIRINOX; Drug: Induction Chemotherapy - Gemcitabine and Nab-Paclitaxel; Radiation: MR-LINAC Guided Radiotherapy; Procedure: Surgical Exploration and Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection Rate
The proportion of all enrolled participants achieving a microscopically margin-negative (R0) resection on final pathology. R0 is defined as a tumor-free margin of ≥1 mm.
Measured: At time of surgical exploration/resection (approximately 6-8 months after study start).
Secondary outcomes (11)
Overall Survival
Time from diagnosis of locally advanced pancreatic cancer (LAPC) to death from any cause.
Measured: From diagnosis up to 5 years after study start.
Progression-Free Survival
Time from diagnosis of LAPC to the first documented radiographic/clinical progression of disease or death from any cause.
Measured: From diagnosis up to 5 years after study start.
Local Control
Time from diagnosis of LAPC to local progression at the primary site.
Measured: From diagnosis up to 5 years after study start.
Distant Metastasis-Free Survival
Time from diagnosis of LAPC to the development of distant metastases.
Measured: From diagnosis up to 5 years after study start.
Pathologic Complete Response (pCR) and Tumor Regression Grade (TRG)
Proportion of patients achieving a pathologic complete response and assessment of tumor regression grade according to CAP criteria in resected specimens.
Measured: At time of surgical exploration/resection (approximately 6-8 months after study start).
Radiographic Response by RECIST v1.1
Assessment of tumor response (Complete Response, Partial Response, Stable Disease, Progressive Disease) using RECIST v1.1 criteria at various pre-specified time points.
Measured: End of Induction Chemotherapy (approx. 4 months), Post-Radiotherapy (approx. 6 months), Pre-operation, and during follow-up (up to 5 years).
CA19-9 Kinetics and Normalization Rate
Changes in CA19-9 tumor marker levels (absolute values, percentage decline, and normalization rates) at pre-specified time points.
Measured: Baseline, post-chemotherapy, post-radiotherapy, pre-operation, 30- and 90-day post-operation, and during surveillance (up to 5 years).
30-day and 90-day Postoperative Morbidity and Mortality
Incidence and grading of perioperative complications (Clavien-Dindo classification) and mortality rates within 30 and 90 days post-surgery.
Measured: 30 days and 90 days following surgical exploration/resection.
Quality of Life (QoL) using SF-20
Assessment of patient-reported quality of life using the Short-Form 20 (SF-20) questionnaire.
Measured: Throughout treatment and during follow-up (up to 5 years).
Surgical Exploration Rate and Conversion-to-Resection Rate
Proportion of enrolled patients who undergo surgical exploration, and among those explored, the proportion who proceed to resection.
Measured: At the time of planned surgical exploration (approximately 6-8 months after study start).
Completion of Planned Chemotherapy and Radiotherapy
Assessment of the rates of completion of the planned chemotherapy and MR-LINAC guided radiotherapy, and incidence of protocol deviations.
Measured: Throughout Induction Chemotherapy (approx. 4 months) and MR-LINAC Radiotherapy (approx. 2 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Casey Allen, MD, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Investigators
- Casey J. Allen, MD, Principal investigator, AHN Division of Surgical Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871461
- Sponsor's protocol ID
- 2026-211
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No