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ASCO GI 2026 | Patient selection and design of the STOPGAP II trial in gastric cancer
Maheswari Senthil, MD, University of California, Irvine, CA, discusses the patient selection criteria for the STOPGAP II trial (NCT04762953), which is currently open and enrolling patients with gastric or GE junction adenocarcinoma and synchronous peritoneal carcinomatosis or cytology-positive disease. The trial design takes into account learnings from previous trials, including selection of patients with peritoneal carcinomatosis, ease of intraperitoneal chemotherapy administration, and intraoperative randomization, allowing for cytoreduction in both arms and continuation of standard of care systemic therapy. This interview took place at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco, CA.
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Transcript
The patient selections for intraperitoneal chemotherapy trial, and I will specifically focus on STOPGAP2, because that is the one that’s currently open and actively enrolling, is it is available for any patient who has gastric or GE junction, SEER-stage 3, adenocarcinoma, with synchronous either cytology-positive disease or peritoneal carcinomatosis. And the main expectation is that the patients must have undergone a minimum of three, max of six months of first-line systemic therapy, and must not have any evidence of visceral metastasis...
The patient selections for intraperitoneal chemotherapy trial, and I will specifically focus on STOPGAP2, because that is the one that’s currently open and actively enrolling, is it is available for any patient who has gastric or GE junction, SEER-stage 3, adenocarcinoma, with synchronous either cytology-positive disease or peritoneal carcinomatosis. And the main expectation is that the patients must have undergone a minimum of three, max of six months of first-line systemic therapy, and must not have any evidence of visceral metastasis. And the reason for this is that, once again, patients with gastric cancer may develop extraperitoneal metastasis. And we want to make sure only the patients with peritoneal only disease are being enrolled in the trial. The progression often happens during the first three to six months, and that is where the inclusion expects the patients to have received the three months, so declaring their biology before enrolling in the trial. So that’s an important part. With regards to the logistical piece itself, once the patients are enrolled in the trial, the intraperitoneal chemotherapy administration is very straightforward. Patients will undergo a diagnostic laparoscopy, and if they get randomized to the intraperitoneal arm, they will have an intraperitoneal port placed. The administration of intraperitoneal chemotherapy is done as an outpatient. Very simple, very straightforward, similar to how the patients are getting their IV treatment. Concurrently, they will have the intraperitoneal chemotherapy administered. And this is important because that’s a very important difference between the other two types of intraperitoneal chemotherapy that we know of, which is HIPEC and PIPEC, which is pressurized intraperitoneal aerosolized chemotherapy, both of which require the chemotherapy to be administered in the operating room. And the patients, it is an actual surgical procedure. It requires hospital stay. Unlike those two approaches with normothermic intraperitoneal paclitaxel, it’s an outpatient. Patient comes and they get their treatment and they can go home the same day. One of the most important aspects of the STOPGAP-2 trial is the study design itself. Once again, it has taken into account all the learnings that we have from the previous trials that have both done well versus have not done well when it comes to peritoneal carcinomatosis. So the three main things with this trial and why I think this is a very important trial is the fact that this actually has a selection for patients with peritoneal carcinomatosis and eliminates the likelihood of progression in visceral sites before the patient gets enrolled. That’s one of the reasons that GASTROPEC trial failed is because 50% of the patients had progression prior to even getting to the treatment. So that’s one important aspect in the trial. The second aspect of the trial is the ease with which the intraperitoneal chemotherapy can be administered, but also intraoperative randomization. So we are really confirming the peritoneal disease burden and making sure it is going to be evenly distributed between the two arms. And in both arms, cytoreduction is possible. I think that’s a very attractive aspect of STOPGAP2 is because surgical removal of all cancer in appropriately selected patients is available in both groups. So because surgery is currently not standard of care for patients with stage four gastric cancer. So when patients are participating in this trial, regardless of which one they get randomized to, they will have something more than standard of care that they would have access to. And I think that makes it a very attractive study design from all aspects. And finally, patients get to continue their standard of care systemic therapy, including targeted therapies. So which also we are not kind of really changing their systemic treatment a whole lot. They are able to get still the best systemic therapy possible in addition to everything else we are doing.
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