Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer
Status:
Not yet recruiting
Trial end date:
2028-06-01
Target enrollment:
Participant gender:
Summary
There have been many high-quality research publications, including the TNT model of
short-term radiotherapy combined with consolidation chemotherapy, and the TNT model of
three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined
with CRT. All have achieved better tumor regression and tumor regression than the standard
CRT model. The higher pCR rate reduces the recurrence and metastasis events, improves the
prognosis, and strives for more opportunities for organ function preservation. Can the TNT
model combined with immunotherapy further increase the cCR rate? Whether immunotherapy can
bring further survival benefits to patients who develop CR after neoadjuvant therapy
(especially W&W after cCR), it is also necessary to carry out corresponding clinical
research. We designed this study for patients with mid-to-low and locally advanced rectal
cancer who want to be able to preserve the anus. TNT mode combined with PD-1 immunotherapy is
given before surgery, and TME surgery is performed on patients who have not reached cCR or
who still require surgery. It provides sufficient evidence for the safety and effectiveness
of preoperative neoadjuvant therapy for PD-1 in low- and middle-level locally advanced rectal
cancer.