New Trial Shows Promise in Preventing Colorectal Cancer Recurrence After Initial Treatment
New York, NY – A phase 2 trial, INTERCEPT-TT (NCT05343013), published recently in the Journal of Clinical Oncology, offers a potential new approach to preventing recurrence in colorectal cancer (CRC) patients who remain at high risk following standard treatment. The study investigated the use of TAS-102,an oral chemotherapy medication,in patients with ctDNA-defined minimal residual disease after completing adjuvant chemotherapy.
Currently, treatment options for CRC patients whose disease returns after initial therapy are limited, often relying on polychemotherapy. Though, the INTERCEPT-TT trial sought to address the critical gap in care for patients who, despite completing standard treatment, continue to show evidence of residual cancer in their bloodstream.
The trial demonstrated that TAS-102 induced circulating tumor DNA (ctDNA) clearance in a meaningful proportion of patients. specifically, 47% and 36% of patients receiving TAS-102 achieved ctDNA clearance at 3 and 6 months, respectively. This contrasts sharply with the synthetic control cohort, where clearance rates were 6.7% at both 3 months ( P = .0034) and 6 months (P = .025).
“ctDNA has the ability for us to look for tiny pieces of DNA from the tumor that might still be present in the bloodstream,” explained Nicholas James Hornstein,MD,PhD,assistant professor at the Donald and Barbara Zucker School of medicine of Hofstra University and Northwell Health,and an author of the study. ”They give us this lead time of somewhere between 6 and 9 months of knowing, ‘Hey, the tumor is probably going to come back, but we don’t have an option for it.'”
The study was designed to determine if intervening with TAS-102 could alter the course of the disease in these high-risk patients. As Dr. Hornstein stated, the core question driving the research was: “Can we change the natural history of the disease if a patient has had all the treatment they’re supposed to get and they’re still ctDNA positive? Can we stop the disease from coming back?”
Despite advancements in early detection through screenings like colonoscopies, approximately one-third of patients with stage II or stage III CRC experience disease recurrence. this trial represents a step towards addressing this challenge and potentially improving outcomes for patients with refractory CRC.
Reference:
Pellatt AJ, Bent A, Hornstein N, et al. Phase II trial of TAS-102 in colorectal cancer patients with circulating tumor DNA-defined minimal residual disease after adjuvant therapy: INTERCEPT-TT. JCO Precis Oncol. 2025;9:e2500142.doi:10.1200/PO-25-00142.
