Study of Plasma Tumor-promoting Factors and Immune Function After Laparotomy, Cytoreductive Surgery and HIPEC vs. PIPAC in Patients With Peritoneal Metastasis

Peritoneal Cancer Clinical Trial

— IMMUNOPAC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04122885
• Other study ID #: 392/2018BO1
• Status: Recruiting
• Start date: October 1, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2019
• Source: University Hospital Tuebingen
• Contact: Marc A Reymond, MD MBA
• Phone: +4970712986722
• Email: marc.reymond[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. PM patients treated with CRS and HIPEC

2. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-Induced Change
• Neoplasm Metastasis
• Peritoneal Cancer

Intervention

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

Procedure:
• Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy
If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of the proteins of interest over time		6 weeks
Secondary	Postoperative complications		30 days
Secondary	Overall survival	Measured from time point of intervention	18 months

External Links

•   Icahn Scholl of Medicine at Mount Sinai
•   University Hospital Tübingen