Clinical trial · Interventional
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
Phase I/II Trial of MOC31PE Immunotoxin in Peritoneal Carcinomatosis From Colorectal Carcinoma
NCT02219893CI-TRIAL-00027854ImmunoPeCacompletedPhase 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
Summary
Brief summary (as posted)
The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).
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 |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOC31PE Immunotoxin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MOC31PE Immunotoxin
- description
- Drug to be instilled on day 1 after cytoreductive surgery and HIPEC.
- interventionNames
- Drug: MOC31PE Immunotoxin
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 5 years or until disease progression
- description
- Follow-up: 5 years from administration of study drug, or until disease progression
Secondary outcomes (5)
- measure
- Cmax, Tmax
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Histologically verified EpCAM positive colorectal cancer * Ambulatory with Eastern Cooperative Oncology Group (ECOG) performance status 0-1 at the time of surgery * At least 18 years of age * Suspected isolated peritoneal carcinomatosis upon radiologic work-up * Complete cytoreduction at surgery and mitomycin C given as standard HIPEC procedure * Peritoneal Cancer Index (PCI) ≤ 20 * Laboratory values at inclusion: * Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L * Platelets \> 100 x 10\^9/L * Hb \> 9g/dL * Creatinine ≤ 2x upper limit of normal * Bilirubin \< 2.0x the upper limit of normal * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2. 5x the upper limit of normal * Albumin levels \> 30 g/L * International normalised ratio (INR) \<1.3 * Signed informed consent and expected cooperation with respect to treatment and follow-up must be obtained and documented according to International Conference of Harmonisation- Good clinical Practice (ICH GCP), and national/local regulations. Exclusion criteria: * Other synchronous metastatic lesions. Patients may be included if they have had curative resection of metastatic CRC disease more than 2 years prior to inclusion and have no relapse at this location is detected. * History of prior other malignant disease the last 3 years, except for adequately treated carcinoma of the cervix or basal or squamous cell skin cancer. * History of central nervous system (CNS)- or bone metastases * Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia * History of any liver disease including Hepatitis B or C infection * Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment * BMI \> 35 * Pregnant or breast-feeding patients * Alcohol or drug abuse * Use of drugs that can influence hepatic function (e.g. phenytoin or phenobarbital) * Use of anticoagulants * Any reason why, in the opinion of the investigator, the patient should not participate in the study protocol
References
Publications (0)
Data not yet available
No reference posted for this study.