UCI Health's STOPGAP II Trial Advances to National Phase for Advanced Gastric Cancer Treatment
Key Insights
UCI Health (search) researchers have successfully launched STOPGAP II, a national phase 2/3 clinical trial supported by the National Cancer Institute to test a novel intraperitoneal chemotherapy approach for advanced gastric cancer (search).
The trial builds on the success of STOPGAP I, which demonstrated the safety and feasibility of combining direct abdominal chemotherapy with systemic therapy for gastric carcinomatosis (search) patients.
Advanced gastric cancer (search) disproportionately affects Hispanic populations in Southern California, with incidence rates of 12 per 100,000 nearly double that of other ethnic groups.
UCI Health (search) oncologists Dr. Maheswari Senthil and Dr. Farshid Dayyani have successfully advanced their innovative gastric cancer (search) treatment approach to a national scale, launching STOPGAP II, a randomized phase 2/3 clinical trial supported by federal funding from the National Cancer Institute. The trial represents a significant milestone in addressing one of the most challenging forms of stomach cancer (search).
Novel Treatment Approach Shows Promise
The STOPGAP II trial builds on the success of the researchers' initial phase 1/2 study, STOPGAP I, which demonstrated the safety and feasibility of administering chemotherapy directly into the abdominal cavity. This innovative approach, known as normothermic intraperitoneal chemotherapy, delivers higher doses of the drug paclitaxel directly into the peritoneum (search) while patients simultaneously receive intravenous chemotherapy.
"Stomach cancer (search) is the fourth-leading cause of cancer deaths worldwide," says Senthil, a surgical oncologist specializing in gastrointestinal cancers. "One of the most feared and common forms spreads to the lining of the abdominal cavity, and once it reaches the advanced stages, patients often have a survival rate of little more than six months."
The comprehensive treatment protocol includes surgery to remove all visible cancerous tissue followed by hyperthermic intraperitoneal chemotherapy to eradicate any remaining microscopic cancer cells. This multi-modal approach is designed to boost survival rates and optimize quality of life for patients battling advanced gastric cancer (search).
Addressing Health Disparities
The urgency of this research is underscored by alarming demographic trends, particularly in Southern California where the trial originated. Recent statistics reveal that gastric cancer (search) incidence among Hispanics reaches 12 people per 100,000, nearly double that of other ethnic groups.
"The factors contributing to this disparity are complex and include diet, lifestyle and genetic predisposition," Senthil explains. "We've observed that many patients present with advanced-stage cancer, which often results in poor outcomes."
The disease increasingly affects younger adults and Hispanic populations, making the development of more effective treatments particularly critical for these communities.
National Expansion and Study Design
STOPGAP II will compare survival outcomes between patients receiving the combination of intraperitoneal chemotherapy and systemic therapy versus those receiving systemic chemotherapy alone. The randomized controlled trial will be conducted at leading cancer centers across the United States, significantly expanding the research scope beyond the initial single-center study.
Since STOPGAP I launched in 2021, the response has been overwhelmingly positive, with participants seeking out this innovative treatment from beyond the local region. The national expansion will allow researchers to systematically study the benefits of this approach across diverse patient populations.
Research Funding and Future Directions
Both researchers credit the UC Irvine Anti-Cancer Challenge with providing crucial seed funding for their initial pilot project. "Without it, we wouldn't have been able to launch STOPGAP or secure further national support," Senthil notes.
Since its inception in 2017, the Anti-Cancer Challenge has raised $6.2 million, funding 123 promising pilot studies and early-phase clinical trials at the Chao Family Comprehensive Cancer Center (search). This support has catalyzed an additional $44.5 million in extramural funding, significantly boosting research efforts at the only National Cancer Institute-designated comprehensive cancer center based in Orange County.
As the trial progresses, both doctors emphasize the continued need for philanthropic support to advance cancer research. "We still have many research questions to answer," Senthil says. "Identifying which patients respond best to our treatments is crucial. The path forward requires sustained support from the community."
The STOPGAP trials represent a potential paradigm shift in treating advanced gastric cancer (search), offering hope for improved outcomes in a disease with historically poor prognosis.