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NCT Number: NCT05644249

PIPAC and FOLFOX for Gastric Cancer Peritoneal Cancer

Peritoneum is among the most common sites of metastases in gastric cancer. Systemic chemotherapy is the current standard for peritoneal carcinomatosis (PC), although, the treatment results remain extremely poor. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a modern treatment modality for PC, that 1) optimize the drug distribution by applying an aerosol rather than a liquid solution; and 2) apply increased intraperitoneal hydrostatic pressure to increase drug penetration to the target. Despite some encouraging preliminary results for PIPAC efficacy, it is still an investigational treatment. Furthermore, only very limited data exist for bidirectional treatment, which includes a combination of systemic chemotherapy and PIPAC. Thus, this study will investigate the feasibility of PIPAC and systemic chemotherapy combination for gastric cancer patients with peritoneal metastases.

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Key information

Conditions

Gastric Cancer Abdominal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationa Cancer Institute, Vilnius, Vilniaus, Lithuania

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About this study

This open-label, single-arm feasibility study will be conducted at two major gastrointestinal cancer treatment centers in Lithuania and will include 37 participants. Gastric cancer patients diagnosed with a synchronous or metachronous peritoneal carcinomatosis based on a clinical, radiological, cytological, and histological examination will be considered for enrollment. Thirty-seven patients willing to participate and meeting the enrollment criteria will be scheduled for the experimental treatment. Three cycles of 1st line palliative systemic chemotherapy will be administered every 28 days and PIPAC with cisplatin 10,5 mg/m2 and doxorubicin 2,1 mg/m2 will be utilized 14 days after each of the systemic chemotherapy cycles. After the 3rd PIPAC procedure patients will be re-assessed and discussed at multidisciplinary team meetings. In case of downstaging patients will be considered for radical gastrectomy±cytoreductive surgery; others for further systemic therapy. All patients will be followed up for 24 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically verified gastric adenocarcinoma (HER2 negative) with peritoneal carcinomatosis;
  • Age≥18;
  • ECOG≤1;
  • Patient willing to participate;
  • Patient is the candidate for 1st line FOLFOX palliative systemic chemotherapy.

Exclusion criteria

  • Extra-abdominal metastases;
  • Siewert I type gastroesophageal junction cancer;
  • Mechanical bowel obstruction;
  • Allergy to study drugs;
  • History of previous intraperitoneal chemotherapy;
  • Pregnancy of refusal for birth-control at least 6 months post-study treatment

Treatment and study plan

Combined Doxorubicin and Cisplatin Pressurized IntraPeritoneal Aerosol Chemotherapy With Systemic FOLFOX chemotherapy

Drug

Each course of combined treatment will start with PIPAC (a pressurized aerosol containing cisplatin 10.5 mg/m2 and doxorubicin 2.1 mg/m2 diluted in NaCl 0.9% applied through the nebulizer inside the abdominal cavity during laparoscopy). Fourteen days afterward 2 cycles of systemic FOLFOX chemotherapy will be applied within 28 days. The interval between combined treatment courses will be 14 days.

Other names: PIPAC

Primary outcomes

  1. Objective tumor response according to RECIST v 1.1 after second PIPAC

    Time frame: Day 7 after second PIPAC procedure (an average of 8 weeks after start of the study)

    Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after second PIPAC procedure

Secondary outcomes

  1. Objective tumor response according to RECIST v 1.1

    Time frame: Day 7 after third PIPAC procedure (an average of 15 weeks after start of the study)

    Objective tumor response according to RECIST v 1.1 in CT scan performed 1 week after third PIPAC procedure

  2. Compliance to treatment

    Time frame: Through study completion, an average of 28 months

    Proportion of patients able to receive all anticipated treatment (3 PIPACs and 6 cycles of FOLFOX)

  3. Postoperative complication assessed by Clavien-Dindo score

    Time frame: Through study completion, an average of 28 months

    The number of patients with postoperative complications, defined and graded according to Clavien-Dindo classification

  4. Peritoneal carcinomatosis index and histological regression according to peritoneal regression grading score (PRGS).

    Time frame: Through study completion, an average of 28 months

    A pathologist blinded to clinical outcomes will evaluate histological tumor response using the Peritoneal Regression Grading Score (PRGS): 1-Complete regression without cancer cells; 2-higher response with prevalence of regressive phenomena and only a few residual cancer cells - PRGS; 3-minor response with prevalence of residual cancer cells and poor regressive phenomena; 4-no response to therapy without regressive phenomena.

    A patient will be considered a responder if any reduction in the PRGS during subsequent biopsies will be recorded.

  5. Ascites volume

    Time frame: Through study completion, an average of 28 months

    The volume of ascites recorded at every PIPAC procedure.

  6. Tumor markers

    Time frame: Through study completion, an average of 28 months

    Ca19-9, carcinoembryonic antigen (CEA), Ca72-4 plasma levels measured at different time points.

  7. Quality of life by EORTC questionnaires

    Time frame: Through study completion, an average of 28 months

    Quality of life by EORTC questionnaires measured at different time points.

  8. Overall survival

    Time frame: From treatment start to death, assessed up to 24 months

    Time from start of the treatment to death

  9. Progression-free survival

    Time frame: From treatment start to death, assessed up to 24 months

    Time from start of the treatment to progression of the disease

  10. Adverse events of chemotherapy drugs

    Time frame: Through study completion, an average of 28 months

    The number of patients with toxicity according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the study period

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Vilnius University Hospital Santaros Klinikos

Registry information

Official study title

Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) and Systemic Chemotherapy as a First-line Treatment for Gastric Cancer Peritoneal Metastases: Open-label, Single-arm, Multi-center Feasibility Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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