Clinical trial · Interventional
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraoperative Peritoneal Chemotherapy(HIPC) With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer
Cytoreductive Surgery Plus Hyperthermic Intraoperative Peritoneal Chemotherapy With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer; the HIPCUpp-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): Insufficient enrollment in Pancreatic \& Biliary arm
Summary
Brief summary (as posted)
The majority of patients with upper gastrointestinal cancer, such as gastric, biliary, or pancreatic carcinoma, present with metastatic disease, and have an extremely poor survival, irrespective the type of treatment modality. The aim of the current monocentric phase II study is to evaluate in these patients the effectiveness of cytoreductive surgery (CRS) plus hyperthermic intraoperative peritoneal chemotherapy with cisplatin (HIPC). The study is designed to have at least 80% power to detect a 40% increase in 1-year overall survival common to all strata (gastric-biliary-pancreas) after CRS+HIPC. Over an anticipated period of 2 years, 60 patients will undergo CRS + HIPC. Translational research will quantify perioperative circulating and peritoneal tumour cells, based on real-time RT-PCR for CEA and EpCAM. Plasma concentration of cytokines will be determined for IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12p70, IL-13, IFN-γ, and VEGF at several time-points. Systemic immunological changes will be assessed by flow cytometric quantification of the relative proportions and absolute numbers of B- and T-lymphocytes, NK cells, effector T cells, HLA-DR+ T cells, and regulatory T cells. Gene-expression studies will be performed using Affymetrix HG U133 Plus 2.0 arrays on primary and metastatic tissue samples.
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 |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CRS+HIPC
- description
- Patients with biliary, gastric, or pancreatic carcinoma and metastatic or recurrent disease confined to the abdominal compartment
- interventionNames
- Procedure: Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC)
Primary outcomes (1)
- measure
- Overall survival time (OS) following CRS+HIPC (from surgery to cancer-related death)
- timeFrame
- 1 year follow-up
- description
- Statistical methodology. The study is designed to have at least 80% power to detect a 40% increase in 1-y OS common to all strata (gastric-biliary-pancreas) after CRS+HIPC. The reference percentages 1-y OS are 52%, 37% and 34% for gastric, biliary and pancreatic cancer, respectively. An exponential distribution is assumed for the event times in the study group with a parameter yielding 72.8%, 51.8% and 47.6% 1-y OS in the mentioned strata. Cancer-specific survival will be monitored using consecutive CT- and/or MRI-scan every 3 months after CRS+HIPC.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Primary or recurrent disease * Histological confirmation of primary (or recurrent) and metastatic disease * Systemic chemotherapy and/or biological is allowed before and/or after CRS+HIPC * Radiotherapy is allowed before or after CRS+HIPC * Patients must not have failed prior intraperitoneal platinum-therapy * Age between 18 to 75 years * Patient Karnofsky performance scale (KPS) \> 80 (normal activity with a bit of effort) Exclusion Criteria: * Age \< 18 or \> 75 years * Pregnancy * Any malignancy other than biliary, gastric, or pancreatic adenocarcinoma * Any metastatic disease outside the abdominal compartment, such as pulmonary or bone metastases * Peritoneal carcinomatosis index (PCI) \> 20 at the start of CRS * Peritoneal residual tumour nodules larger than 2.5 mm after CRS (CCR-2) * Clinical relevant ascites * More than 3 liver metastases * Solitary liver metastasis larger than 5 cm
References
Publications (2)
- DERIVEDTopal B, Demey K, Topal H, Jaekers J, Van Cutsem E, Vandecaveye V, Sagaert X, Prenen H. Cytoreductive surgery and Hyperthermic intra-operative peritoneal chemotherapy with Cisplatin for gastric peritoneal Carcinomatosis Monocentric phase-2 nonrandomized prospective clinical trial. BMC Cancer. 2017 Nov 17;17(1):771. doi: 10.1186/s12885-017-3730-6. PMID 29149865
- DERIVEDJanky R, Binda MM, Allemeersch J, Van den Broeck A, Govaere O, Swinnen JV, Roskams T, Aerts S, Topal B. Prognostic relevance of molecular subtypes and master regulators in pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Aug 12;16:632. doi: 10.1186/s12885-016-2540-6. PMID 27520560