Clinical trial · Interventional
Patient-derived-organoid (PDO) Guided Versus Conventional Therapy for Advanced Inoperable Abdominal Tumors
Patient-derived-organoid (PDO) Guided Versus Conventional Therapy for Advanced Inoperable Abdominal Tumors: a Multicenter Open-label, Proof of Concept, Phase 2 Randomised Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no funding support
Summary
Brief summary (as posted)
Recent studies that ex vivo drug responses on PDO models across different solid tumours can predict treatment responses to chemotherapeutic agents. In patients with metastatic or inoperable solid abdominal tumours, we perform a PDO based drug screen and to identify drugs that will confer clinical response and compared to conventional treatments
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Organoids | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PDO-guided treatment | Drug | — | UNRESOLVED |
| standard of care | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PDO-guided treatment
- description
- A biopsy of the tumour will be performed for PDO culture and Genome-guided drug screening. An Multidisciplanary Tumour Board will review the drug screen results and recommend the use of a drug with a response in a PDO.
- interventionNames
- Drug: PDO-guided treatment
- type
- EXPERIMENTAL
- label
- standard of care
- description
- the standard of care will include all treatments that have been reported to improve survival or quality of life in randomized trials.
- interventionNames
- Drug: standard of care
Primary outcomes (1)
- measure
- Tumor progression-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * patients should be older than 18 years, able to provide written consents to trial participation, with Eastern cooperative oncology group performance status of 0 or 1, With measurable disease in accordance with response evaluation criteria in solid tumours (RECIST) version 11. \[ 10 \] With a neutrophil count, hemoglobin \> 9g/dl, serum creatinine \<1.5 x upper limit of normal, serum bilirubin \< 1.5 x normal, and aspartate and alanine aminotransferases (\<3 x ULN or \<5x in those with liver metastasis) Ejection Fraction \>50% of normal. The disease is accessible for a biopsy (radiologic or endoscopic) or resection of a metastatic site. Exclusion Criteria: * unable to give consent, could not obtain a biopsy
References
Publications (0)
Data not yet available