NCT07020247

Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for LARC: PALACE Study

Personalized Long-course Radiotherapy Plus Chemotherapy With or Without Immunotherapy for Locally Advanced Rectal Cancer：A Randomized Controlled Study (PALACE Study)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, randomized controlled, phase III clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) sustained for over one year) of patients with locally advanced rectal cancer(LARC) treated with personalized long-course radiotherapy plus chemotherapy with or without Serplulimab. A total of 184 patients were included in this study.

Detailed description

Patients diagnosed with locally advanced rectal cancer (T3-4/N+) and presenting with combined risk factors, where the lower boundary of the lesion is ≤ 10 cm from the anal margin, will undergo neoadjuvant therapy. The primary endpoint of the study is the complete response rate (CR), defined as the combination of pathological complete response (pCR) and clinical complete response (cCR) sustained for over one year.

Conditions

• Locally Advanced Rectal Cancer (LARC)
• Immunotherapy
• Radiotherapy
• Total Neoadjuvant Therapy
• Anal Function Preservation

Interventions

Type	Name	Description
DRUG	Anti-PD-1 antibody drug named Serplulimab	Serplulimab
RADIATION	Radiotherapy	Radiotherapy is delivered using intensity-modulated radiotherapy (IMRT/VMAT) at a dose of 50-50.4Gy/ 25-28f(1.8-2.0Gy/d, 5f/w). For patients in the experimental group who achieve partial remission (PR) or better during the induction phase, an additional local boost dose of 6Gy/3f(2.0Gy/d, 5f/w) is administered to the PGTV.(No PGTV dose was given in the control group). For the treatment of lymph node metastasis in the lateral pelvic wall outside the mesorectal area: no additional dose is required when surgery is feasible, a sequential boost dose of 15Gy/3f is added when the lymph nodes are not surgically resectable.
DRUG	Chemotherapy	Capox

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-07-31
• Completion: 2028-01-31
• First posted: 2025-06-13
• Last updated: 2025-06-13

Locations

1 site across 1 country: China