NCT06853769

Neoadjuvant Therapy for Locally Advanced Rectal Cancer

A Prospective, Single-arm, Single-center Exploratory Clinical Study of Anlotinib in Combination With Penpulimab and Conventional Chemoradiotherapy for the Neoadjuvant Treatment of Locally Advanced Rectal Cancer

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer

Detailed description

Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy Chemotherapy: Capecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride,Penpulimab	Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-08-01
• Completion: 2027-08-01
• First posted: 2025-03-03
• Last updated: 2025-03-03

Locations

1 site across 1 country: China