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The clinical efficacy of neoadjuvant chemoradiotherapy with immunotherapy for the organ preservation of T1-2N0-1M0 ultra low rectal cancer: a prospective randomized controlled multicenter clinical study

ABSTRACT: Interventions: Neoadjuvant chemoradiotherapy:Long-term radiotherapy and chemotherapy were used to irradiate the primary tumor and high-risk areas with a tumor dose of 50 Gy (2Gy/time × 25 times); simultaneous administration of capecitabine single-agent chemotherapy during radiotherapy;Neoadjuvant chemoradiotherapy + immunotherapy:Long-term radiotherapy and chemotherapy were used to irradiate the primary tumor and high-risk areas with a tumor dose of 50 Gy (2Gy/time × 25 times); capecitabine and PD-1 antibody (200mg/3 weeks) were administered simultaneously during radiotherapy. After the radiotherapy, two courses of PD-1 antibody (200mg/3weeks×2) Primary outcome(s): Clinical complete regression rate of tumors;Pathological complete regression rate of tumors;Rate of anus preservation;Rate of rectum preservation Study Design: Parallel

DISEASE(S): Colorectal Cancer

PROVIDER: 2697610 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:For locally advanced rectal cancer, the initial goal of neoadjuvant chemoradiotherapy is to reduce local recurrence, but the pathologic complete response (PCR) rate is low, and distant metastasis becomes the main treatment failure pattern. With the gradual optimization of neoadjuvant chemotherapy regimens, the tumor regression efficacy in patients has improved, leading to increased organ preservation and reduced distant metastasis. Therefore, neoadjuvant treatment for locally advanced rectal cancer has transitioned from an era focused on local control of recurrence to an era focused on improving tumor regression, organ preservation, and long-term survival. Thus, there is a trend towards intensifying the whole course of neoadjuvant treatment for rectal cancer to preserve organ function. The combination of chemotherapy, immunotherapy, and radiotherapy is currently the most powerful approach to maximize tumor regression and achieve organ preservation in low rectal cancer. Currently, several clinical studies on the use of PD-1 inhibitors in combination with preoperative chemoradiotherapy for locally advanced rectal cancer are ongoing internationally, with the majority focusing on PD-1 monotherapy or PD-1 combined with the CapOX regimen in combination with synchronous chemoradiotherapy as neoadjuvant treatment. However, there is no specific research reported on the use of PD-1 combined with FOLFOXIRI regimen in combination with synchronous chemoradiotherapy as a whole course neoadjuvant treatment for pMMR (proficient mismatch repair) locally advanced rectal cancer. Based on the above evidence from evidence-based medicine, we plan to conduct a phase II prospective clinical study to explore the efficacy and treatment safety of PD-1 monoclonal antibody and FOLFOXIRI chemotherapy combined with intensity-modulated radiotherapy as a whole course neoadjuvant treatment in pMMR locally advanced low rectal cancer. The results of this study may open up new treatment approaches for optimizing whole course neoadjuvant chemotherapy in locally advanced rectal cancer and provide a novel treatment strategy for organ preservation in pMMR rectal cancer.

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The clinical efficacy of neoadjuvant chemoradiotherapy with immunotherapy for the organ preservation of T1-2N0-1M0 ultra low rectal cancer: a prospective randomized controlled multicenter clinical study

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