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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2NCT07827053

Clinical Study of Radiotherapy Combined With Adebrelimab and NALIRIFOX for Conversion Therapy in Locally Advanced Pancreatic Cancer

A Phase 2 study testing Adebrelimab (PD-L1 inhibitor), NALIRIFOX and SBRT in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study intends to explore conversion therapy for locally advanced pancreatic cancer (LAPC). The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma (PDAC)
What is being tested?
Adebrelimab (PD-L1 inhibitor), NALIRIFOX and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 1 Sep 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form
  • Age 18-75 years
  • Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
  • Locally advanced disease as determined by the investigator (with reference to the CSCO Clinical Practice Guidelines for Pancreatic Cancer)
  • No prior treatment for pancreatic cancer, including radiotherapy, chemotherapy, or surgery
  • At least one measurable lesion according to RECIST v1.1 criteria
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  • ECOG performance status score of 0-1
  • Adequate organ function based on laboratory tests performed within 28 days prior to the first dose:
  • Complete blood count:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L Platelet count ≥ 75 × 10⁹/L Hemoglobin ≥ 90 g/L
  • Blood biochemistry:
  • Serum albumin ≥ 30 g/L Serum total bilirubin ≤ 1.5 × ULN ALT and AST ≤ 3 × ULN Serum creatinine (Cr) ≤ 1.5 × ULN; or creatinine clearance calculated by the Cockcroft-Gault formula > 50 mL/min
  • International normalized ratio (INR) ≤ 1.2, or prothrombin time (PT) exceeding the normal range by ≤ 2 seconds
  • Urine protein < 2+ (if urine protein ≥ 2+, 24-hour urine protein quantification is required; patients with 24-hour urine protein < 1.0 g are eligible) Male subjects and female subjects of childbearing potential must use contraceptive measures from the first dose until 6 months after the last dose of the study drug

Who cannot join

  • Presence of distant metastasis
  • Contraindications to surgical resection of pancreatic cancer
  • History of another malignancy other than pancreatic cancer within 5 years prior to enrollment, or concurrent malignancy at the time of enrollment
  • Prior allogeneic stem cell transplantation or solid organ transplantation
  • Symptomatic active central nervous system (CNS) metastases and/or carcinomatous meningitis, or uncontrolled major seizure disorder, unless ruled out by CT or MRI
  • History of uncorrectable electrolyte disturbances, including serum potassium, calcium, or magnesium abnormalities
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  • Current interstitial pneumonia or interstitial lung disease, history of interstitial pneumonia or interstitial lung disease requiring corticosteroid therapy, or any other condition that may interfere with the assessment and management of immune-related pulmonary toxicity; active pulmonary tuberculosis
  • Active autoimmune disease or history of autoimmune disease with potential for recurrence
  • Use of immunosuppressive agents or systemic corticosteroids for the purpose of immunosuppression within 2 weeks prior to enrollment
  • Active infection, unexplained fever ≥ 38.5°C within 1 week prior to enrollment, or baseline white blood cell count > 15 × 10⁹/L; use of oral or intravenous therapeutic antibiotics within 2 weeks prior to enrollment
  • Congenital or acquired immunodeficiency (e.g., HIV infection)
  • Receipt of a live attenuated vaccine within 4 weeks prior to enrollment, or anticipated need for such vaccination during adebrelimab treatment or within 60 days after the last dose
  • Clinically significant bleeding symptoms or evident bleeding tendency within 6 months prior to enrollment; known hereditary or acquired bleeding tendency or thrombotic tendency
  • Major vascular disease, arterial thromboembolism
  • Uncontrolled or poorly controlled cardiac clinical symptoms or disease, such as:
  • New York Heart Association (NYHA) Class > II heart failure, or left ventricular ejection fraction (LVEF) < 50% as assessed by color Doppler echocardiography
  • Unstable angina pectoris
  • Myocardial infarction within 1 year prior to initiation of study treatment
  • Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
  • QTc interval > 450 ms (males) or > 470 ms (females) (QTc calculated using Fridericia's formula; if the QTc value is abnormal, measurements should be repeated three times at 2-minute intervals and the average value taken) Uncontrolled pleural effusion, pericardial effusion, or moderate or greater ascites
  • Hypertension not adequately controlled with antihypertensive medication (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); history of hypertensive crisis or hypertensive encephalopathy
  • Presence of severe, non-healing or dehisced wounds, active ulcers, or untreated fractures
  • Major surgery (excluding diagnostic surgery) within 4 weeks prior to enrollment, or planned major surgery during the study period
  • History of intestinal obstruction and/or clinical symptoms or signs of gastrointestinal obstruction within 6 months prior to enrollment
  • Known allergy or hypersensitivity to any study drug or excipient
  • Participation in another clinical study of an investigational drug within 4 weeks prior to enrollment
  • Pregnant or breastfeeding women
  • Other factors that, in the opinion of the investigator, render the subject unsuitable for study participation

About this study

This study intends to explore conversion therapy for locally advanced pancreatic cancer (LAPC). The intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion.

For subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy.

Read more

For subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer.

For subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.

Being tested
Adebrelimab (PD-L1 inhibitor), NALIRIFOX, SBRT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adebrelimab (PD-L1 inhibitor)Drug

    Also called Adebrelimab

    20 mg/kg, intravenous infusion, administered on Day 1, every 3 weeks as one cycle (Q3W)

  • NALIRIFOXDrug

    Oxaliplatin: 60 mg/m², intravenous infusion over 2 hours, administered on Day 1 Irinotecan Liposome: 50 mg/m², intravenous infusion for more than 90 minutes, administered on Day 1 LV (Leucovorin): 400 mg/m², intravenous infusion over 2 hours, administered on Day 1 5-FU (5-Fluorouracil): 2400 mg/m², continuous intravenous infusion for 46 hours Every 3 weeks is defined as one treatment cycle (Q3W)

  • SBRTRadiation

    Target Volume Delineation: The gross tumor volume GTV1 is delineated on CT images. A 1 cm inward contraction from GTV1 is performed to generate GTV-lattice, within which small spherical volumes GTV-sbrt with a diameter of 1-1.5 cm are created, and the spacing between adjacent spheres is 3 times the sphere diameter.

    Prescription Fractionation: Simultaneous integrated boost radiotherapy is adopted, with the prescription dose: GTV-sbrt: 24 Gy in 3 fractions; GTV1: 9 Gy in 3 fractions.

Study groups in NCT07827053
Study groupRoleWhat they receive
LPAC+NALIRIFOX+AdebrelimabExperimentalThe intervention starts with modified stereotactic body radiation therapy (3-day regimen), followed by systemic therapy within 1-2 weeks after irradiation. Subsequently, the investigator will evaluate the resectability of the lesion. For subjects converted to resectable status, surgical resection will be performed, followed by postoperative adjuvant therapy. For subjects who remain unresectable but maintain stable disease, a second cycle of conversion therapy will be continued. If the lesion is converted to resectable, surgical resection will be performed followed by adjuvant therapy. If disease progression occurs, subsequent treatment will be carried out in accordance with the first-line treatment for advanced pancreatic cancer. For subjects who experience disease progression or distant metastasis, subsequent treatment will be administered by adjusting the chemotherapy regimen in accordance with the first-line standard regimen for advanced pancreatic cancer.
Receives: Drug: Adebrelimab (PD-L1 inhibitor); Drug: NALIRIFOX; Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. surgical conversion rate

    The proportion of patients who become eligible for surgery after treatment, relative to the total number of patients.

    Measured: 3 years

Secondary outcomes (8)

  1. R0/R1 Resection Rate

    The proportion of patients who achieve R0 (microscopically margin-negative) or R1 (microscopically margin-positive) resection among all patients who undergo surgery. R0 is defined as no residual tumor at the resection margin; R1 is defined as microscopic residual tumor at the resection margin.

    Measured: in 3 years

  2. pCR

    Pathological Complete Response: The absence of residual invasive tumor cells in the resected primary tumor specimen and/or lymph nodes upon pathological evaluation.

    Measured: in 3 years

  3. MPR

    Major Pathological Response: The presence of ≤10% viable residual tumor cells in the resected primary tumor specimen upon pathological evaluation.

    Measured: in 3 years

  4. ORR

    The proportion of patients who achieve a best overall response of either complete response (CR) or partial response (PR) as assessed by RECIST v1.1 (or other specified criteria) from the start of treatment until disease progression or initiation of subsequent anticancer therapy.

    Measured: in 3 years

  5. EFS

    The time from the date of treatment initiation to the date of first occurrence of any of the following events: disease progression that precludes surgery, local or distant recurrence, or death from any cause. Patients who are event-free at the time of data cutoff are censored at the date of their last disease assessmen

    Measured: in 3 years

  6. OS

    The time from the date of treatment initiation to the date of death from any cause. Patients who are alive at the time of data cutoff are censored at the date of last known follow-up.

    Measured: in 3 years

  7. the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs)

    Safety endpoints include the incidence, severity, and relationship to study treatment of adverse events (AEs) and serious adverse events (SAEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

    Measured: in 3 years

  8. Immune Age Rejuvenation

    Defined as a reduction in immune age of ≥3 years compared to the baseline measurement, as calculated by the immune age estimation model based on the data generated from the specified assay kit.

    Measured: in 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2029 (estimated)
  4. Study completion1 Sep 2030 (estimated)

Resources

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
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827053
Sponsor's protocol ID
IIT2026-249
Status last verified
Sep 2026
First submitted
27 Aug 2026
Last updated
18 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab (PD-L1 inhibitor), NALIRIFOX and SBRT in people with Pancreatic Ductal Adenocarcinoma (PDAC), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.

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 14 inclusion and 28 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: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

surgical conversion rate (time frame: 3 years). 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 NCT07827053.

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 18 Sep 2026.

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