Radar de Ensayos Clínicos

Progression-Free Survival (PFS) in MRD-Negative and MRD-Positive Groups

The primary outcome is progression-free survival (PFS), stratified by minimal residual disease (MRD) status. PFS is defined as the time from treatment initiation to the first occurrence of tumor recurrence, disease progression, or death from any cause, whichever occurs first. Tumor assessments are performed every 3-4 months for up to 24 months using imaging (CT or MRI) and serum tumor markers (CEA and CA19-9). Blood samples are collected at predefined time points to determine MRD status via ctDNA analysis, which informs individualized treatment decisions. Differences in PFS between MRD-negative and MRD-positive groups are evaluated using the Kaplan-Meier method and log-rank test, with hazard ratios (HRs) and 95% confidence intervals (CIs) estimated using Cox proportional hazards regression.

From treatment initiation through 24 months, with assessments at each follow-up visit every 3-4 months.

Objective Response Rate (ORR)

Proportion of patients with tumor volume reduction ≥30% and maintained for ≥4 weeks, including complete response (CR) and partial response (PR).

Assessed at the first tumor evaluation visit, 8 weeks after treatment initiation.

Overall Survival (OS)

Time from treatment initiation to death from any cause.

Monitored continuously from treatment initiation through 24 months, with survival status updated every 3-4 months.

Disease-Free State (NED)

Absence of detectable tumor via imaging and clinical examination after treatment.

Evaluated at each follow-up visit during the 24-month period.

ctDNA and cfRNA Dynamic Changes

Longitudinal changes in ctDNA and cfRNA levels in blood samples collected at multiple time points.

Measured via NGS sequencing at predefined time points: before conversion therapy, 3-6 weeks after conversion therapy, within 2 months after surgery or non-radical treatment, and during follow-up.