Clinical trial · Interventional
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
NCT02008539CI-TRIAL-00026639TREAT-ME 1terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment terminated after 13 patients (14 planned); further patients did not meet eligibility criteria to receive autologous IMP
Summary
Brief summary (as posted)
To evaluate the safety and tolerability of MSC\_apceth\_101.
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 |
|---|---|---|---|
| Advanced Gastrointestinal Cancer | Malignant Digestive System Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSC_apceth_101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment arm
- interventionNames
- Drug: MSC_apceth_101
Primary outcomes (1)
- measure
- Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
- timeFrame
- day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma. * Premature or scheduled termination of standard therapy * Progressive disease as clinically assessed by the investigator * Max. tumour lesion ≤ 5 cm * Adequate organ function * Ability of patient to understand character and individual consequences of clinical trial * Age ≥ 18 years * Written informed consent must be available before any study specific procedure is performed Exclusion Criteria: * Patients with severe heart diseases * Clinical significant ischemic disease during the last 4 weeks before Visit 1 * Severe lung disease * Symptomatic peritoneal carcinomatosis * Symptomatic pleural or pericardial effusion * Serious uncontrolled acute infections less than 3 weeks before Visit 1 * Known dependency on alcohol or other drugs * Patients requiring corticoids in doses above the Cushing threshold * Known liver fibrosis or liver cirrhosis * Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator * Female patient who is pregnant or breast feeding * Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
References
Publications (0)
Data not yet available
No reference posted for this study.