drugset / Trial / NCT06608537

A Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer

NCT06608537 ↗

Phase 2 Completed 52 enrolled Sun Yat-sen University
NaSingle-groupOpen-labelDiagnostic

Summary

The combination of short course radiotherapy and immunotherapy helps to increase the proportion of pathological complete response after neoadjuvant therapy, providing more patients with the opportunity for organ preservation. However, there is no accurate and unified cCR diagnostic standard in the world. As a new radiotracer, 18F-FAPI has been developed and used to target fibroblast activating protein and tumor matrix visualization, which has the advantages of low background uptake, high contrast, few preparation requirements, short post-injection interval, and no influence on blood glucose. Therefore, we will invite you to participate in a clinical study to explore whether the PET parameters of 18F-FDG and 18F-FAPI-42 PET/CT can be used to predict pathological responses after neoadjuvant therapy for locally advanced rectal cancer (LARC). The findings will help improve future treatment stratification of LARC, help patients preserve organs and improve quality of life.

Timeline

Start
2024-12-01
Primary completion
2025-07-30
Completion
2025-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject Sintilimab Monoclonal antibody 3 mg/kg Intravenous

Indications