Abstract 118TiP
Background
Surgical resection remains the mainstay of curative-intent treatment for CRLM. Preoperative care, including chemotherapy or combined with immunotherapy (IO), has increased the proportion of patients (pts) eligible for curative-intent surgery. However, microsatellite stability (MSS) tumors are less likely to respond to IO. Based on the synergy of IO and anti-angiogenesis, their combination may lead to improved response in MSS CRLM. SCT510 is a recombinant anti-VEGF antibody, which has demonstrated equivalent safety, pharmacokinetics, and immunogenicity to bevacizumab. Finotonlimab is a novel anti-PD-1 agent and has proved effective for treating solid tumors. Herein, we conducted a prospective phase II study (NEO CPLUS) to evaluate the efficacy and safety of neoadjuvant CAPOX plus SCT510 and finotonlimab in high-risk resectable CRLM.
Trial design
NEO CPLUS is a multicenter, single-arm, investigator-initiated phase II study (ChiCTR2400085958). Approximately 100 patients will be enrolled. Eligible pts are aged 18-75 years and have histologically confirmed, resectable, high-risk (clinical risk score ≥3) CRLM. Resectability is defined as the technical ability to achieve complete resection, with only liver metastasis, and ≤6 metastatic tumors. Pts must have an ECOG PS of 0-2, MSS/pMMR disease, and adequate organ function. Pts will receive 3 cycles of CAPOX (130 mg/m2 oxaliplatin, day [D] 1 + 1000 mg/m2 capecitabine, D1-14, bid), SCT510 (7.5 mg/kg, D1) and finotonlimab (200 mg, D1), followed by 1 cycle of CAPOX plus finotonlimab in 21-day cycle. After 2-4 cycles, patients who are assessed as having a radiological response or stable disease per RECIST 1.1 will proceed with surgery within 4-6 weeks and be allowed to receive 4 cycles of adjuvant CAPOX plus SCT510. The primary endpoint is pathologic complete response. Secondary endpoints include 1-year progression-free survival rate, major pathological response, R0 resection, R1 resection, and safety.
Clinical trial identification
ChiCTR2400085958.
Legal entity responsible for the study
The authors.
Funding
SinoCellTech Ltd.
Disclosure
All authors have declared no conflicts of interest.