Clinical trial · Observational
Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis
Study of Plasma Tumor-promoting Factors and Immune Function After Explorative Laparotomy, Tumor Debulking and HIPEC (Hyperthermic Intraperitoneal Chemotherapy) vs. PIPAC (Pressurized IntraPeritoneal Aerosol Chemothereapy) in Patients With Peritoneal Metastasis as Evaluated by Serum Proliferative Activity, Levels of Proteins, Cytokines, Circulating Growth Factors, Inhibitors and Their Binding Proteins.
- 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 general goal of this study is to investigate the effect of treatment on serum concentrations of proteins known to impact angiogenesis or tumor growth and establishment in patients with peritoneal metastasis of various origin. Since the immune system is thought, by many, to have an impact on tumor growth and development, this study also seeks to determine the impact of abdominal surgery on postoperative immune function in PM patients, as judged by proteins known to influence immune function. This study will not only characterize the postoperative plasma but also to determine if the magnitude of any of the changes noted is associated with a worse or improved oncologic outcome. The principle purpose of this study is to gather perioperative serum/plasma samples from patients with PM from a variety of different primary tumors (ovarian, gastric, and colorectal) undergoing either CRS and HIPEC versus PIPAC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Change | — | UNRESOLVED | — |
| Peritoneal Cancer | Malignant Peritoneal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy | Procedure | — | UNRESOLVED |
| PIPAC with oxaliplatin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CRS and HIPEC
- description
- Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
- interventionNames
- Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
- label
- PIPAC
- description
- Pressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible)
- interventionNames
- Combination Product: PIPAC with oxaliplatin
Primary outcomes (1)
- measure
- Serum levels of the proteins of interest over time
- timeFrame
- 6 weeks
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Adult patients (18 years of age or older) with ovarian, gastric, or colorectal cancer who have PM who after thorough evaluation are deemed candidates for: * CRS \& HIPEC if complete cytoreductive surgery is possible (OR) * PIPAC if no complete cytoreductive surgery is possible at the University Hospital of Tubingen are eligible for entry in this study Exclusion Criteria: * ASA 3 \& 4 patients * Patients who have received chemotherapy within 1 month prior to the planned surgery * Patients who have received blood transfusion(s) within 2 weeks of the planned surgery * Patients in whom the treatment plan includes systemic chemotherapy to be given during the first 2 weeks after surgery. * History of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin * Severe renal impairment, myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias * Immunocompromised patients such as those taking an immunosuppressive medication and those who have a known disease of the immune system * Patients or family members involved in the planning and conduct of the study (applies to University of Tübingen staff involved) * Pregnancy
References
Publications (0)
Data not yet available