P-320Pilot trial of YIV-906 with neoadjuvant chemoradiotherapy (CRT) in patients with locally advanced rectal cancer

Introduction: Neoadjuvant CRT is the standard of care for clinical stage T3-4 or node positive rectal adenocarcinoma, but it is associated with a 12% rate of acute grade 3-4 diarrhea and 9% rate of longterm gastrointestinal (GI) toxicities1. Furthermore, the rate of complete pathologic responses to neoadjuvant therapy is low in historic studies (8%)1. Reducing GI toxicity is important because these side effects can lead to delayed or incomplete treatment, which may compromise patient outcomes. Novel agents which may improve pathologic response are of interest, as pCR is associated with improved local control and survival. YIV-906 is derived from Huang-Qin-Tang, a traditional Chinese medicine used to treat GI ailments. YIV-906 is a standardized pharmaceutical subjected to quality-control measures including chemical fingerprinting, individual target bioassays, and genomic bioresponse profiling. Phase I/II clinical trials demonstrated the safety of YIV-906 in combination with irinotecan- and capecitabine-based chemotherapy and a reduction in GI side effects. In addition, these studies suggest that YIV-906 may enhance the tumor response to chemotherapy by altering the expression of pro-inflammatory cytokines. In a preclinical study, YIV-906 selectively decreased intestinal injury from abdominal radiation (RT) without compromising tumor control. Therefore, a pilot phase I trial was launched to evaluate the novel combination of YIV-906 with neoadjuvant CRT for rectal cancer.
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research