Answer for stomach cancer

• STOPGAP 2 is a national randomized controlled trial designed to study the role of a novel chemotherapy approach for patients with advanced stomach cancer.
• The National Institutes of Health supports the trial.
• It is based on the success of a UC Irvine phase 2 clinical trial called STOPGAP 1.

UCI Health's Dr. Maheswari Senthil and Dr. Farshid Dayyani are a dynamic duo working together to tackle the challenges of stomach cancer. They recently completed a phase 2 clinical trial focused on combating a form of it called gastric cancer, a disease that disproportionately affects Hispanics and younger adults.

That innovative trial, called STOPGAP 1, addresses a pressing need for effective treatments against gastric carcinomatosis - a stage of stomach cancer in which the disease has spread to the abdominal cavity, resulting in grim survival prognoses. The success of this trial paved the way to approval of their next step - a large, national randomized controlled phase 2/3 clinical trial called STOPGAP 2.

STOPGAP 2 is supported by federal research funding from the National Cancer Institute, a division of the National Institutes of Health.

"Stomach cancer is the fourth-leading cause of cancer deaths worldwide," says Senthil, a surgical oncologist who specializes 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. This is especially concerning in our community, where we serve a large Hispanic population that's experiencing rising incidence rates."

An innovative treatment approach

To address this, Senthil and Dayyani investigated the feasibility of administering chemotherapy directly into the abdominal cavity - a procedure known as normothermic intraperitoneal chemotherapy - combined with systemic therapy. This technique allows higher doses of the chemotherapy drug paclitaxel to be administered directly into the affected area, while patients simultaneously receive intravenous chemotherapy.

Demonstration of the safety and feasibility of this approach has resulted in approval of STOPGAP 2, which will compare the survival outcomes of patients treated with a combination of intraperitoneal chemotherapy and systemic therapy to those of systemic therapy alone.

Participants in the trial also undergo surgery to remove visible cancerous tissue, followed by hyperthermic intraperitoneal chemotherapy to eradicate any remaining microscopic cancer cells. This comprehensive approach is designed to boost survival rates and optimize the quality of life for patients battling advanced stomach cancer.

An important step forward

The STOPGAP 2 trial represents an important step forward to address a critical gap in the treatment of patients with advanced stomach cancer and has the potential to change the treatment approaches.

The urgency of this research - and the need for greater philanthropic funding in this arena - is underscored by alarming trends. In Southern California, recent statistics reveal that the 12 people per 100,000 gastric cancer incidence rate among Hispanics is nearly double that of other ethnic groups.

"The factors contributing to this disparity are complex and include diet, lifestyle and genetic predisposition," Senthil says. "We've observed that many patients present with advanced-stage cancer, which often results in poor outcomes."

Since the launch of the STOPGAP trial in 2021, the response has been overwhelmingly positive, with participants seeking out this innovative treatment from beyond the local region. Now, with the launch of STOPGAP 2 in leading institutions across the country, Senthil and her team will be able to systematically study the benefits of this approach.

As the trial progresses, both doctors emphasize the need for continued philanthropic efforts to fuel 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."

Support from the Anti-Cancer Challenge

Both doctors credit initial Anti-Cancer Challenge funding with making this research possible. "Without it, we wouldn't have been able to launch STOPGAP or secure further national support," Senthil says, adding that additional philanthropic assistance would help UCI Health tackle broader challenges.

Since its inception in 2017, the Anti-Cancer Challenge has brought in an impressive $6.2 million, funding 123 promising pilot studies and early-phase clinical trials. The initiative has also catalyzed an additional $44.5 million in extramural funding for UC Irvine researchers, significantly boosting cancer research efforts.

UC Irvine's 2025 Anti-Cancer Challenge will take place on campus on Saturday, Oct. 11. Registration is currently open.