City of Hope’s Phase 1 Clinical Trial Data Is Part of the Society of Surgical Oncology Annual Meeting’s Press Program

Targeted chemotherapy in the abdomen using a technique called PIPAC combined with systemic standard-of-care chemotherapy is shown to be safe, with promising activity for patients with colorectal and appendiceal cancer that has spread to the abdominal cavity

A phase 1 clinical trial led by City of Hope^®, one of the largest and most advanced cancer research and treatment organizations in the U.S. with its National Medical Center named top 5 in the nation for cancer by U.S. News & World Report, has demonstrated the safety and early efficacy of targeted chemotherapy using PIPAC combined with systemic chemotherapy for patients with colorectal and appendiceal cancer that has spread to the peritoneum of the abdominal cavity. This data will be presented at a March 18 press briefing spotlighting some of the most consequential research to be shared at this year’s Society of Surgical Oncology Annual Meeting (SSO).

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Mustafa Raoof, M.D., M.S., assistant professor in City of Hope’s Division of Surgical Oncology (Photo: City of Hope)

Of all the possible sites that cancer can spread to, the abdomen’s peritoneum is the worst when it comes to survival rates because it is difficult for systemic chemotherapy to reach this region due to a low number of blood vessels. When surgery is not an option and peritoneal metastases are left untreated, these patients survive only a few months and few make it past one year with standard treatment.

“Up until recently, delivering a uniform dose of chemotherapy in the abdomen has not been possible. At City of Hope, we have been evaluating the use of pressurized intraperitoneal aerosolized chemotherapy, or PIPAC, which is the most optimized way to deliver chemotherapy in the abdominal cavity. It increases targeted medicinal exposure while limiting toxicity,” said Mustafa Raoof, M.D., M.S., assistant professor in City of Hope’s Division of Surgical Oncology and first author of the SSO abstract entitled “Dose escalation Phase 1 trial of Mitomycin C Pressurized Intraperitoneal Aerosolized Chemotherapy in Combination with Systemic Chemotherapy for Unresectable Appendiceal and Colorectal Carcinomatosis,” which will be featured in the SSO press briefing at 9 a.m. PST on March 18.

The Society of Surgical Oncology is an international community of cancer surgeons and care professionals who are shaping advances in the delivery of the highest quality surgical care for cancer patients. City of Hope was the first U.S. institution to offer PIPAC in a clinical trial, and has hosted the first and second U.S. PIPAC training workshops.

The City of Hope-led multicenter phase 1 trial, in collaboration with Northwell Health and Mayo Clinic in Florida, included 19 patients with a median age of 60 who had colorectal or appendiceal cancer that had spread to the peritoneum and was inoperable even after four months of first- or second-line systemic chemotherapy. These patients received treatments that included Mitomycin C chemotherapy targeted to the abdomen via PIPAC and standard-of-care FOLFIRI systemic chemotherapy. This combination treatment is necessary to maximize the medicinal delivery via systemic and regional exposure.

“While we were able to demonstrate safety in this study, what we are really excited about is the early efficacy results seen as measured by several response criteria — histologic, laparoscopic, radiographic and tumor marker CEA,” Dr. Raoof said. “This trial provides strong rationale for a multicenter randomized trial, which City of Hope will open soon. The new trial will determine if the addition of PIPAC to standard therapy could both improve survival and preserve quality of life. At this time, we caution against off-label use of PIPAC until the definitive efficacy of PIPAC in this population is proven.”

In addition to Dr. Raoof’s oral abstract to be presented March 28 at 8:26 p.m. ET in TCC Ballroom BC, City of Hope also will have five poster abstracts at SSO 2025 happening March 27 to 29 in Tampa, Florida:

• P64: Genetic Pathogenic Variants in Asian American/Pacific Islander Women with Breast Cancer: Implications for Surgical and Oncologic Care
  
  Presenter: Jennifer Tseng, M.D.

• P167: Impact of Systematic Discontinuation of Mitomycin C HIPEC for Colorectal Peritoneal Metastasis on Oncologic Outcomes at an NCI Cancer Center
  
  Presenter: Muhammad Talha Waheed, M.D.

• P187: Upfront Colectomy vs. Initial Appendectomy followed by Completion Colectomy for Appendiceal Cancer: Comparison of Outcomes
  
  Presenter: Muhammad Talha Waheed, M.D.

• P453: Percutaneous Transesophageal Gastrostomy as an Alternative Approach for Palliative Decompression of Malignant Bowel Obstruction
  
  Presenter: Kristofor Olson, M.D., Ph.D.

• P114: Reduced hepatotoxicity and equivalent survival with a lower hepatic arterial floxuridine starting dose in the adjuvant treatment of colorectal cancer liver metastases
  
  Presenter: Kevin Labadie, M.D.

About City of Hope

City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas. City of Hope’s affiliated group of organizations includes Translational Genomics Research Institute and AccessHope^TM. For more information about City of Hope, follow us on Facebook, X, YouTube, Instagram and LinkedIn.

About the Society of Surgical Oncology

The Society of Surgical Oncology is a dynamic global community of cancer surgeons and cancer care professionals shaping advancements to deliver the highest quality surgical care for cancer patients. SSO promotes leading-edge research, quality standards and knowledge exchange, connecting members of the cancer care team worldwide to continuously improve cancer outcomes. Our highly regarded educational webinars, mentorship programs, the Society’s clinical journal, Annals of Surgical Oncology, the Society’s open-access journal, Surgical Oncology Insight, and society events, including SSO 2025, inspire members and spur each cancer surgeon and member of the cancer care team to grow, improve, and thrive professionally and personally.

Please contact Amber Kukulka, SSO senior marketing manager, at amberkukulka@surgonc.org with any questions about SSO or the SSO 2025 meeting.

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