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Pancreatic Ductal AdenocarcinomaPhase 1/2NCT06345599

PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)

A Phase 1/2 study testing Radiotherapy, Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab and Chemotherapy:Albumin-bound paclitaxel、Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Second Affiliated Hospital of Soochow University.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
Radiotherapy, Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab and Chemotherapy:Albumin-bound paclitaxel、Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
1 May 2024to 10 Jan 2027
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 ≤ 75 years；no gender limitations
  • Histopathologically and/or cytologically confirmed ductal adenocarcinoma of the pancreas, the patient has fresh pathological tissue and the tumour is located in the head and neck or body of the pancreas
  • Locally advanced pancreatic cancer, borderline resectable or unresectable, without metastases.
  • Life expectancy >= 3 months.
  • ECOG score 0-1.
  • Have at least 1 measurable lesion according to RECIST 1.1 criteria.
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  • No prior treatment with abdominal radiotherapy, chemotherapy and PD-1/PD-L1 antibody.
  • Adequate organs functions as defined by the following laboratory values (completed within 14 days prior to registration): (1) haemoglobin >= 90 g/L (no blood transfusion within 14 days)； (2) neutrophil count > 1.5x10^9/L； (3) platelet count >= 100x10^9/L； (4) total bilirubin <= 1.5xULN (upper limit of normal)； (5) blood glutamic transferase (ALT) or blood glutamic transferase (AST) <= 2.5xULN (6) endogenous creatinine clearance >= 60 ml/min (Cockcroft's AST). (ALT) or blood albumin transaminase (AST) <= 2.5xULN； (6) endogenous creatinine clearance >= 60 ml/min (Cockcroft-Gault formula)； (7) cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%. (8) International normalised ratio (INR) of prothrombin time ≤ 1.5 and partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal in patients who have not received anticoagulation. Patients receiving full or parenteral anticoagulant therapy may enter a clinical trial as long as the dose of anticoagulant has been stable for at least 2 weeks prior to entry into the clinical study and the results of coagulation assays are within the limits of local therapy.
  • No congestive heart failure, unstable angina, unstable arrhythmia in the last 6 months.
  • No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities or immunodeficiencies.
  • Patient must be able to understand the potential risks and benefits associated with this study. Patient able to give informed consent and would likely to comply with the study parameters.

Who cannot join

  • Pregnant or breastfeeding women
  • Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical cancer in situ.
  • Patients with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorders whose clinical severity, in the judgement of the investigator, may prevent the signing of informed consent or affect the patient's adherence to drug therapy.
  • Severe heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months.
  • Organ transplants requiring immunosuppressive therapy
  • Active infection or, in the investigator's judgement, significant haematological, renal, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant disease
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  • Allergy to any of the study drug ingredients
  • History of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy
  • During acute or chronic tuberculosis infection (patients with a positive T-spot test and suspicious tuberculosis foci on chest radiographs).
  • Other conditions considered by the investigator to be unsuitable for enrolment.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Wei Chen, Doctor contact

18626205529

trybest1971@163.com

About this study

Official title: Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)

The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer.

Being tested
Radiotherapy, Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab, Chemotherapy:Albumin-bound paclitaxel、Gemcitabine
Keywords
Locally Advanced Pancreatic Ductal Adenocarcinoma, Chemotherapy, Neoadjuvant Treatment, PRaG Therapy

What participants receive

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

  • RadiotherapyRadiation

    This study is a phase I clinical study. The study is divided into phases Ia and Ib. Phase Ia is a dose-escalation experiment, divided into two cohorts based on radiotherapy dose, with 3+3 patients per cohort for a total of 12 patients. The first group undergoes two cycles of radiotherapy: 24Gy:8Gy3f d4-d6. The second group undergoes one cycle of radiotherapy: 40Gy:8Gy5f d3-d7. Phase II consists of 40 patients who choose the radiotherapy dose based on the results of phase I.

  • Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、CadumilimabDrug

    GM-CSF treatment: GM-CSF 200μg was started on the day of radiotherapy, and was subcutaneously injected daily for 7 consecutive days; d1-d7 Cadumilimab: use 375mg of cadumilimab within one week after radiotherapy

  • Chemotherapy:Albumin-bound paclitaxel、GemcitabineDrug

    Albumin-bound paclitaxel 125mg/m2 d1, d8 Gemcitabine 1000mg/m2 d1, d8 After 3 cycles of neoadjuvant combination treatment with cadumilimab, the patient's surgical status will be evaluated. If surgery is possible, the patient will continue with another 3 cycles of treatment post-operation.

Study groups in NCT06345599
Study groupRoleWhat they receive
Experimental groupExperimentalRadiotherapy、Immunotherapy、Chemotherapy
Receives: Radiation: Radiotherapy; Drug: Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab; Drug: Chemotherapy:Albumin-bound paclitaxel、Gemcitabine

What is being measured

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

  1. Adverse events

    From the beginning of treatment, record the treatment-related toxic reactions that occur in patients.

    Measured: 36 months

  2. Serious adverse events

    From the start of treatment, record any severe adverse reactions that occur in the patient.

    Measured: 36 months

  3. 1-year overall survival

    Record the 1-year overall survival rate of patients after receiving treatment

    Measured: The 1-year overall survival rate of patients after receiving treatment

Secondary outcomes (5)

  1. Objective response rate

    The lesions were evaluated according to the RECIST1.1 standard, and the proportion of patients with the best treatment response of CR and PR after treatment to the total number of evaluable cases was calculated.

    Measured: 36 months

  2. Disease control rate

    The lesions were evaluated according to the RECIST1.1 standard, and the proportion of patients with optimal treatment response of CR, PR, and SD after treatment was calculated based on the total number of evaluable cases.

    Measured: 36 months

  3. Overall survival

    The time from the first day of enrollment to the occurrence of death due to any reason. Patients who are still alive at the time of analysis will use the date of their last contact as the deadline.

    Measured: 36 months

  4. R0 resection rate

    The tumor was completely removed during surgery, and the resection margin was negative under microscopic observation.

    Measured: 36 months

  5. Progression free survival

    The time between the start of treatment and the observation of disease progression or death for any reason. Patients who are still alive at the time of analysis will use the date of their last contact as the cutoff date.

    Measured: 36 months

Timeline

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

  1. First posted3 Apr 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion10 Jan 2027 (estimated)
  4. Study completion10 Jan 2027 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345599
Sponsor's protocol ID
LK2023100
Status last verified
Mar 2024
First submitted
1 Feb 2024
Last updated
3 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Radiotherapy, Immunotherapy:Granulocyte macrophage-colony stimulating factor(GM-CSF)、Cadumilimab and Chemotherapy:Albumin-bound paclitaxel、Gemcitabine in people with Pancreatic Ductal Adenocarcinoma, run by Second Affiliated Hospital of Soochow University.

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 11 inclusion and 10 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 3 Apr 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Wei Chen, Doctor (18626205529, trybest1971@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: 36 months). The study lists 3 primary outcomes in all. 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 NCT06345599.

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 3 Apr 2024.

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