RP2 + Chemotherapy for Gastroesophageal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called RP2, injected directly into tumors in the stomach and esophagus. The goal is to determine if combining RP2 with standard chemotherapy is safer and more effective at shrinking cancer before surgery compared to chemotherapy alone. The study seeks individuals with specific types of stomach or esophageal cancer that have not spread, who can undergo surgery, and have normal organ function. Participants should not have received previous cancer treatments for their current condition.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in cancer treatment.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop all current medications, but you cannot be on certain medications like anticoagulants that can't be safely stopped, systemic antivirals, or high-dose corticosteroids. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that RP2 is likely to be safe for humans?
Research shows that RP2, when injected directly into tumors, is under study to assess its safety. Early results suggest increased understanding of how RP2 interacts with standard chemotherapy. This combination, known as FLOT, already treats gastroesophageal cancer.
Patients who have undergone similar treatments have demonstrated that RP2 is generally well-tolerated. However, like any new treatment, some side effects may occur. Common chemotherapy side effects include fatigue and nausea. Careful monitoring during the trial tracks any new or unexpected issues.
As a Phase 2 study, earlier stages have already assessed RP2's safety. This phase focuses more on its effectiveness while still monitoring safety. If the treatment were unsafe, it would not have reached this phase. Overall, RP2 remains under study, with the goal of ensuring its safety for patients.12345Why do researchers think this study treatment might be promising?
Unlike the standard of care for gastroesophageal cancer, which typically involves chemotherapy regimens like FLOT, RP2 offers a novel approach by using a genetically modified oncolytic virus. This virus is designed to selectively infect and destroy cancer cells, potentially enhancing the effectiveness of chemotherapy. Researchers are excited about RP2 because it not only targets cancer cells more directly but also stimulates the body's immune response to fight the cancer, offering a dual-action approach that could improve outcomes for patients.
What evidence suggests that RP2 with chemotherapy might be an effective treatment for gastroesophageal cancer?
Research has shown that injecting RP2 directly into tumors may enhance the effectiveness of the standard chemotherapy treatment known as FLOT. In this trial, participants will receive a combination of RP2 and FLOT. FLOT alone has a 77% success rate in shrinking tumors in patients with advanced gastroesophageal cancer, with 66% of patients experiencing some reduction in tumor size and 11% seeing their tumors disappear completely. By combining RP2 with FLOT, the aim is to improve these results by directly targeting cancer cells. Previous studies with similar combinations have shown promise in shrinking tumors before surgery. The expectation is that RP2 will boost FLOT's ability to kill cancer cells, potentially leading to better overall outcomes.16789
Who Is on the Research Team?
William Chapin, MD, MSCE
Principal Investigator
Abramson Cancer Center at the University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for individuals with confirmed non-metastatic esophageal, gastroesophageal junction, or gastric adenocarcinoma that's at least stage T2 or node positive. Participants must be in good physical condition (ECOG 0-1), considered suitable for surgery by a qualified surgeon, and have certain blood counts and liver/renal function within specified ranges.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intra-tumoral injections of RP2 in combination with preoperative FLOT chemotherapy
Surgical Resection
Surgical resection of the tumor is performed after completion of neoadjuvant treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including overall survival and disease-free survival
What Are the Treatments Tested in This Trial?
Interventions
- RP2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abramson Cancer Center at Penn Medicine
Lead Sponsor
Replimune Inc.
Industry Sponsor