NCT04906044

Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer

Total Neoadjuvant Treatment Plus PD-1 in Mid-Low Locally Advanced Rectal Cancer (STARS-RC03)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tislelizumab
• Locally Advanced Rectal Cancer
• Total Neoadjuvant Treatment
• PD-1

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab combined withTotal Neoadjuvant Treatment

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-10-18
• Completion: 2026-06-01
• First posted: 2021-05-28
• Last updated: 2023-11-18

Locations

1 site across 1 country: China