drugset / Trial / NCT06665087

CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC

NCT06665087

Phase 2 Not yet recruiting 110 enrolled Fudan University
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a prospective, multicentre, cohort study. For cohort 1(CGA cohort), experimental cohort, older or Frail patients with metastatic colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive single agent chemotherapy, with/without targeted therapy, and BSC; Fit patients will receive doublet chemotherapy, with/without targeted therapy, and BSC. For cohort 2 (external control cohort), external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected. The primary endpoint is Progression Free Survival (PFS). The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, quality of life (QoL), the Overall Response Rate (ORR), 1-year Disease-specific survival (DSS) rate, 1-year overall survival (OS) rate etc.

Timeline

Start
2024-11
Primary completion
2027-11
Completion
2028-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule
Subject Irinotecan Small molecule
Subject Oxaliplatin Small molecule
Subject Raltitrexed Small molecule
Subject Sintilimab Monoclonal antibody
Subject fluorouracil Small molecule