Using lab-grown mini-tumors from pancreatic cancer tissue to predict and improve post-surgery treatment for pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsklinikum Ulm AöR

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Neoplasms [C04], Diseases [C] - Digestive System Diseases [C06]

Trial duration

29 Sep 2025 → ongoing

Decision date (initial)

2025-07-01

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Deutsche Krebshilfe (DKH)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

Trial part I: Feasibility of treatment selection by an organoid-based approach in the adjuvant setting within 12 weeks after surgery in more than 60% of the resected PDAC.
Trial part II: DFS at 18 months from start of organoid-based adjuvant treatment.

Secondary objectives 12

1. Trial part I: Organoid establishment in more than 75% of the resected PDAC
2. Trial part I: Organoid expansion and characterization in more than 60% of the resected PDAC
3. Trial part I: Rate of organoid-based change of adjuvant treatment regime from standard mFOLFIRINOX treatment
4. Trial part I: Comparison of organoid establishment, expansion and characterization as well as treatment outcome between the different sites establishing organoids
5. Trial part II: Time from surgery to start of adjuvant treatment
6. Trial part II: Rate of patients receiving adjuvant treatment
7. Trial part II: DFS in organoid-based treatment selection with and without mFOLFIRINOX
8. Trial part II: OS in organoid-based treatment selection with and without mFOLFIRINOX
9. Trial part II: Comparison of DFS and OS by organoid-based adjuvant treatment with historical controls from the PRODIGE 24 trial
10. Trial part II: Correlation of CT imaging (radiomics) with R0 resection rate, DFS, OS, Ca19-9 and biomarker behaviour
11. Trial part II: Health related quality of life (EORTC QLQ-PAN26, QLQ-C30 questionnaires)
12. Trial part II: Safety and toxicity of organoid-based adjuvant treatment

Conditions and MedDRA coding

Patients with functionally resectable pancreatic ductal adenocarcinoma (PDAC) according to NCCN criteria and Ca19-9 <500 U/ml (without relevant cholestasis)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 19

1. General: Signed informed consent according to ICH/GCP and national/local regulations (informed consent is given for both part I and part II of the trial at enrolment; participation in translational research is voluntary)
2. General: ECOG performance status 0-1
3. General: Age ≥ 18 years
4. Trial part I: Suspected pancreatic ductal adenocarcinoma (PDAC), resectable according to NCCN criteria, Ca19-9 <500 U/ml (without relevant cholestasis), ≤ cT3 with no prior tumor specific treatment
5. Trial part I: No evidence of metastases to distant organs (e.g. liver, peritoneum, lung)
6. Trial part I: Suitable for adjuvant treatment with mFOLFIRINOX
7. Trial part II: Histologically confirmed PDAC
8. Trial part II: R0 or R1 resection
9. Trial part II: Start of adjuvant chemotherapy within 12 weeks after tumor resection
10. Trial part II: No evidence of postoperative tumor recurrence/metastases by radiological assessment
11. Trial part II: Clinically eligible for all adjuvant treatment regimens foreseen in this trial
12. Trial part II: Sufficient convalescence from surgery and revision surgeries if applicable
13. Trial part II: Postoperative Ca19-9 <180 U/ml (starting from POD 14)
14. Trial part II: Organoid-based chemotherapy recommendation available
15. Trial part II: Creatinine clearance ≥ 30 ml/min
16. Trial part II: Serum total bilirubin level 1.5 - 3 x ULN
17. Trial part II: ALT and AST ≤ 2.5 x ULN
18. Trial part II: White blood cell count ≥ 3.5 x 10^6/ml, neutrophil granulocytes count ≥ 1.5 x 10^6/ml, platelet count ≥ 100 x 10^6/ml
19. Trial part II: Women of Childbearing Potential (WOCBP, defined as not postmenopausal and not surgically or congenitally sterile) whose male partners are potentially fertile (e.g. no vasectomy) or males that are potentially fertile with WOCBP-partner must use highly effective contraception methods for the duration of the trial and for at least 15 months (male or female) after last dose of trial drug (IMP). Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Highly effective birth control methods that result in a failure rate of less than 1% per year include hormonal contraception, intrauterine device, bilateral tubal occlusion, vasectomized partner. Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the patient.

Exclusion criteria 20

1. General: R2 resection or metastatic PDAC by radiological criteria or macroscopic aspect intraoperatively
2. General: Neoadjuvant treatment for PDAC
3. General: Chronic infectious diseases, immune deficiency syndromes, including evidence of clinically relevant, active hepatitis B, C or HIV infection
4. General: Premalignant hematologic disorders, e.g. myelodysplastic syndrome
5. General: Disability to understand and sign written informed consent document
6. General: Past (last 3 years) or current history of malignancies except for the indication under this trial and curatively treated: a. Basal and squamous cell carcinoma of the skin | b. In-situ carcinoma of the cervix | c. Other malignant disease without recurrence after at least 2 years of follow-up
7. General: Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 6 months before enrolment
8. General: History of or evidence upon physical examination of CNS disease unless adequately treated (e.g. primary brain tumor, seizure not controlled with standard medical therapy or history of stroke)
9. General: Pre-existing neuropathy > grade I (NCI CTCAE V 5.0)
10. General: Known dihydropyrimidine dehydrogenase (DPD) deficiency (will be tested in all patients receiving fluoropyrimidine treatment)
11. General: Severe non-healing wounds, ulcers or bone fractures
12. General: Evidence of bleeding diathesis or coagulopathy
13. General: Patients not receiving therapeutic anticoagulation must have an INR ≤ 1.4 and PTT ≤ 40 sec within 28 days prior to enrolment. The use of full dose anticoagulants is allowed as long as the INR or PTT is within therapeutic limits (according to the medical standard in the institution)
14. General: Pregnant, lactating or women of childbearing potential without a negative pregnancy test (serum) within 7 days prior to trial inclusion, irrespective of the method of contraception used
15. General: Patients with known allergies to the trial drugs or to any of its excipients
16. General: Clinically relevant interstitial lung disease, e.g. non-infectious pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease
17. General: Participation in another clinical trial affecting endpoints (within the last 14 days prior to enrolment or 5 plasma half-lives of the used investigational drug, whatever is longer)
18. General: Any psychological, familial, sociological or geographical condition potentially compromising compliance with the trial protocol and the follow-up schedule; those conditions should be discussed with the patient prior to enrolment in the trial
19. General: Person of legal age who is incapable of comprehending the nature, significance and implications of the clinical trial and of determining his/her will in the light of these facts
20. Trial part II: Patients not treated according to recommendation of Organoid Board

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Trial part I: Feasibility of treatment selection by an organoid-based approach in the adjuvant setting within 12 weeks after surgery in more than 60% of the resected PDAC.
2. Trial part II: DFS at 18 months from start of organoid-based adjuvant treatment.

Secondary endpoints 12

1. Trial part I: Organoid establishment in more than 75% of the resected PDAC
2. Trial part I: Organoid expansion and characterization in more than 60% of the resected PDAC
3. Trial part I: Rate of organoid-based change of adjuvant treatment regimen from standard mFOLFIRINOX treatment
4. Trial part I: Comparison of organoid establishment, expansion and characterization as well as treatment outcome between the different sites establishing organoids
5. Trial part II: Time from surgery to start of adjuvant treatment
6. Trial part II: Rate of patients receiving adjuvant treatment
7. Trial part II: DFS in organoid-based treatment selection with and without mFOLFIRINOX
8. Trial part II: OS in organoid-based treatment selection with and without mFOLFIRINOX
9. Trial part II: Comparison of DFS and OS by organoid-based adjuvant treatment with historical controls from the PRODIGE 24 trial
10. Trial part II: Correlation of CT imaging (radiomics) with R0 resection rate, DFS, OS, Ca19-9 and biomarker behaviour
11. Trial part II: Health related quality of life (EORTC QLQ-PAN26, QLQ-C30 questionnaires)
12. Trial part II: Safety and Toxicity of organoid-based adjuvant treatment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsklinikum Ulm AöR

Sponsor organisation

Universitaetsklinikum Ulm AöR

Address

Albert-Einstein-Allee 29, Eselsberg Eselsberg

City

Ulm

Postcode

89081

Country

Germany

Scientific contact point

Organisation

Universitaetsklinikum Ulm AöR

Contact name

Studiensekretariat Innere Medizin I | Prof. Seufferlein

Public contact point

Organisation

Universitaetsklinikum Ulm AöR

Contact name

Studiensekretariat Innere Medizin I | Prof. Seufferlein

Third parties 1

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 18 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications