Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis (IMMUNOPAC)
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|ClinicalTrials.gov Identifier: NCT04122885|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
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.
|Condition or disease||Intervention/treatment|
|Peritoneal Cancer Chemotherapy-Induced Change||Combination Product: PIPAC with oxaliplatin Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy|
The plasma samples obtained in this protocol will also be used to study the various plasma proteins that influence immune function as well as those that influence angiogenesis. In addition to the proteins mentioned above, there are also a large number of other proteins that have not been investigated thus far in the perioperative window; these proteins also merit assessment. The plasma obtained via this study and protocol will also be used to search for other tumor growth factors influenced by surgery or to investigate the impact of surgery on immune function.
Aim 1: To determine perioperative serum levels, over time, of a variety of serum proteins including but not limited to IGFBP-3, VEGF, Ang 2, PlGF, sVCAM, CHI3L1, MMP-2, MMP-3, MCP-1 and proteins that influence immune function as well as other proteins in the following 2 groups of patients:
- PM patients treated with CRS and HIPEC
- PM patients treated with PIPAC.
Aim 2: To compare the perioperative blood protein results between the 2 different groups of patients.
Aim 3: To determine, within each group, a possible correlation between the magnitude of these effects on oncological outcome (patient overall survival).
Aim 4: To search for other surgery-influenced plasma or cellular factors that may influence early postoperative tumor growth or that hold promise as tumor or prognostic markers.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||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.|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2022|
CRS and HIPEC
Cyroreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Procedure: Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C
Other Name: CRS and HIPEC
Pressurized IntraPeritoneal Aerosol Chemotherapy (if CRS and HIPEC not possible)
Combination Product: PIPAC with oxaliplatin
Oxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure
- Serum levels of the proteins of interest over time [ Time Frame: 6 weeks ]
- Postoperative complications [ Time Frame: 30 days ]
- Overall survival [ Time Frame: 18 months ]Measured from time point of intervention
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04122885
|Contact: Marc A Reymond, MD MBAfirstname.lastname@example.org|
|Contact: Philipp Horvath, MDemail@example.com|
|University Hospital Tübingen||Recruiting|
|Tübingen, Germany, 72076|
|Contact: Verena Schlaich +4970712986722 firstname.lastname@example.org|
|Sub-Investigator: Rami Archid, MD|
|Sub-Investigator: Philipp Horvath, MD|
|Sub-Investigator: Giorgi Nadiradze, MD|
|Principal Investigator:||Marc A Reymond, MD MBA||National Center for Pleura and Peritoneum|