Comparing Two Ways to Deliver Chemotherapy Directly into the Abdomen for Peritoneal Cancer Spread (CHARLIE-2 Trial) HIPEC vs PIPAC
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Altpeter S, Lewis C, Sherry C ... Randomized trial of heated vs pressurized/aerosolized chemotherapy (HIPEC vs. PIPAC) for peritoneal carcinomatosis (CHARLIE-2 Trial, NCT07282834). Surgical Oncology Insight, 2026; 3
What is this study about?
When cancer spreads to the lining of the abdomen—a condition called peritoneal carcinomatosis (PC)—it can cause serious symptoms such as abdominal pain, fluid buildup (ascites), bowel obstruction, weight loss, and poor quality of life. PC is most commonly seen in cancers of the digestive tract, appendix, ovaries, and other abdominal organs.
Doctors sometimes treat PC by delivering chemotherapy directly into the abdominal cavity, a strategy known as intraperitoneal (IP) chemotherapy. Two commonly used approaches are:
HIPEC (Hyperthermic Intraperitoneal Chemotherapy): heated liquid chemotherapy circulated throughout the abdomen.
PIPAC (Pressurized Intraperitoneal Aerosol Chemotherapy): chemotherapy delivered as a pressurized aerosol (mist) during minimally invasive surgery.
Although both treatments are used in clinical practice, no previous randomized trial has directly compared them. The CHARLIE-2 study was designed to address this important gap.
Who will participate?
The trial plans to enroll approximately 200 adults with peritoneal carcinomatosis who:
Are between 18 and 80 years old
Have already received at least three months of standard chemotherapy
Still have cancer present in the abdomen
Are not candidates for complete surgical removal of their cancer (cytoreductive surgery) at the time they enter the study.
How will the study work?
Participants will be randomly assigned to receive either:
HIPEC, or
PIPAC.
Patients will undergo three treatment cycles, approximately six weeks apart. After the third treatment, doctors will reassess the cancer using laparoscopy (a minimally invasive surgical procedure) and biopsies.
What are the researchers measuring?
The main goal is to determine which treatment is:
Safer
Better tolerated by patients
Associated with fewer side effects and complications.
Researchers will evaluate:
Treatment-related side effects
Length of hospital stay
Pain medication use
Quality of life using patient questionnaires.
The study will also examine:
Changes in tumor burden
Biopsy evidence of cancer response
Tumor marker levels
The ability of treatment to make future surgery possible
Overall treatment costs.
Why is this study important?
Both HIPEC and PIPAC are widely used, but doctors do not yet know which approach offers the best balance of effectiveness, safety, and quality of life for patients who cannot undergo complete surgical tumor removal.
The results of CHARLIE-2 may help:
Improve treatment recommendations
Identify which patients are most likely to benefit from each approach
Standardize care across cancer centers
Inform future research on intraperitoneal chemotherapy.
What are the study's limitations?
The study is being conducted at a single medical center, which may limit how broadly the results apply to all patients. In addition, participants have cancers arising from different organs, which can make treatment outcomes more difficult to compare. The researchers plan to account for these differences during analysis.
Bottom Line
The CHARLIE-2 trial is the first randomized study to directly compare HIPEC and PIPAC in patients with peritoneal carcinomatosis who are not candidates for complete surgical removal of their disease. By evaluating safety, quality of life, treatment response, and cost, this study aims to determine which approach may provide the greatest benefit for patients facing this challenging condition.
