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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC)
- 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 group | Role | What they receive |
|---|---|---|
| LPAC+NALIRIFOX+Adebrelimab | Experimental | 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. 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.
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)
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
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
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
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
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
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
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
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.
- First posted18 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Long, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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