Abstract 120TiP
Background
Neoadjuvant chemoradiotherapy (CRT) is the standard treatment for locally advanced rectal cancer (LARC) as it effectively lowers the risk of local recurrence. However, the risk of distant metastasis remains comparatively high. Several clinical trials have suggested that the combination of short-course radiotherapy (SCRT) and PD-(L)1 inhibitor is likely to improve tumor response and prognosis. Cadonilimab (AK104), a novel bispecific antibody simultaneously targeting PD-1 and CTLA-4, is designed to boost anti-tumor activity with improved safety profile.Thus, Cadonilimab, to SCRT combined with chemotherapy might further increase the clinical beneft and prognosis for LARC patients.
Trial design
This phase II, single-center, single-arm clinical trial aims to evaluated the efficacy and safety of preoperative SCRT combined with CAPEOX (capecitabine and oxaliplatin) and cadonilimab in the treatment of LARC. Patients with histologically confirmed T3-4/N+M0 rectal adenocarcinoma will be enrolled. Other key eligibility criteria include: 18-70 years old, ECOG PS 0-1, treatment-naive and normal organ function. Patients (pts) receives 1 cycle of CAPEOX plus AK104 (10mg/kg iv, d1, q3w) followed by SCRT (25 Gy with daily fractions of 5 Gy, administered at d8-12 ) and 2 cycles of CAPEOX plus AK104 (10mg/kg iv, d1, q3w). Total mesorectal excision(TME) is performed 2 weeks after the last cycle of neoadjuvant treatment. After surgery, pts receive 5 cycles of adjuvant CAPEOX treatment. The primary endpoint is pathological complete response (pCR) rate.The secondary endpoints include major pathologic response rate (MPR), R0 resection rate, 1 and 3-year DFS rate, 1 and 3-year OS rate and safety. A Simon two-stage design was used. If 6 or more of the 15 patients achieved pCR in the first stage, another 22 pts would be accrued to the second stage. Tumor tissues and blood samples are collected for further exploration. As of June 2024, 10 patients have been enrolled. Clinical trial identification ChiCTR2300075658.
Clinical trial identification
Legal entity responsible for the study
Chuangqi Chen.
Funding
Akeso Biopharma Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.