ClinicalTrials.gg
Not yet recruitingNCT07827053Updated Sep 18, 2026

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

A Phase 2 interventional study of Adebrelimab (PD-L1 inhibitor) and NALIRIFOX in Pancreatic Ductal Adenocarcinoma (PDAC), sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pancreatic Ductal Adenocarcinoma (PDAC)
03

In context

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 182 studies on the registry; 108 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Signed form

Age 18-75 years

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 according to v1.1 criteria

performance status score of 0-1

Adequate organ function based on laboratory tests performed within 28 days prior to the first dose:

  1. Complete blood count:

    (ANC) ≥ 1.5 × 10⁹/L count ≥ 75 × 10⁹/L ≥ 90 g/L

  2. Blood biochemistry:

    Serum albumin ≥ 30 g/L Serum total ≤ 1.5 × and AST ≤ 3 × ULN Serum creatinine (Cr) ≤ 1.5 × ULN; or calculated by the Cockcroft-Gault formula > 50 mL/min

  3. (INR) ≤ 1.2, or prothrombin time (PT) exceeding the normal range by ≤ 2 seconds
  4. 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 must use measures from the first dose until 6 months after the last dose of the study drug

Exclusion criteria

Exclusion Criteria:

  • Presence of distant

to surgical resection of pancreatic cancer

History of another other than pancreatic cancer within 5 years prior to enrollment, or concurrent malignancy at the time of enrollment

Prior 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

Current interstitial pneumonia or interstitial lung disease, history of interstitial pneumonia or interstitial lung disease requiring therapy, or any other condition that may interfere with the assessment and management of immune-related pulmonary toxicity; active pulmonary tuberculosis

Active disease or history of autoimmune disease with potential for recurrence

Use of 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., infection)

Receipt of a within 4 weeks prior to enrollment, or anticipated need for such vaccination during adebrelimab treatment or within 60 days after the last dose

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:

  1. (NYHA) Class > II heart failure, or (LVEF) \< 50% as assessed by color Doppler echocardiography
  2. Unstable angina pectoris
  3. Myocardial infarction within 1 year prior to initiation of study treatment
  4. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention
  5. > 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 to any study drug or

Participation in another clinical study of an 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

Terms in these criteria, in plain language(31)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    LPAC+NALIRIFOX+Adebrelimab

    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. 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.

    Drug: Adebrelimab (PD-L1 inhibitor) · Drug: NALIRIFOX · Radiation: SBRT

Interventions

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

    Also known as: Adebrelimab

  • DrugNALIRIFOX

    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)

  • RadiationSBRT

    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.

06

What researchers measure

Primary outcomes

  1. surgical conversion rate

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

    Time frame: 3 years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: in 3 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2026
First posted
Sep 18, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2029
CompletionEst.
Sep 1, 2030
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07827053
Responsible party
Jiang Long (Chief Physician, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Sep 18, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2029 (estimated)
Completion
Sep 1, 2030 (estimated)
Last update
Sep 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Adebrelimab

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