NCT06770270

Pucotenlimab Plus Radiotherapy and Chemotherapy for Neoadjuvant Treatment of Locally Advanced Rectal Cance(PUCRT)

Pucotenlimab Combined With Radiotherapy and Chemotherapy as Neoadjuvant Therapy for Locally Advanced Rectal Cancer: A Single-Arm Clinical Study(PUCRT)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Colorectal cancer is a common gastrointestinal tumor, with rising incidence in China. Rectal cancer accounts for nearly half of new cases, and many patients are diagnosed at a locally advanced stage. Neoadjuvant chemoradiotherapy (nCRT) is the standard treatment, but only 20-30% achieve a complete response, with many experiencing recurrence or metastasis. Immunotherapy, particularly PD-1/PD-L1 inhibitors, has shown promise in improving outcomes, especially in dMMR/MSI-H patients. However, most rectal cancer patients have MSS, where combining immunotherapy with nCRT has shown moderate success in clinical trials. This project aims to explore the safety and efficacy of PD-1 inhibitor (pucotenlimab) combined with nCRT for locally advanced rectal cancer, potentially offering new treatment options.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Pucotenlimab	Pucotenlimab combined with long-course concurrent chemoradiotherapy, followed by two cycles of pucotenlimab combined with chemotherapy, and then based on tumor response, TME surgery or a "watch and wait" strategy will be adopted.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-12-31
• Completion: 2030-06-30
• First posted: 2025-01-13
• Last updated: 2025-09-04

Locations

1 site across 1 country: China