CTC vs Radiography as the Evidence of Recurrence in Colorectal Cancer Patients

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study enrolled patients who underwent R0 resection of tumor and had elevated tumor biomarkers (CEA, CA19-9). After enroll the study, a CTC test will performed and patients who had positive CTC will be randomly assigned to two groups. The control group will continue follow-up until radiological recurrence appear, the treatment group will start treatment or change the current adjuvant regimen. First endpoint is OS. The secondary endpoint is DFS, adverse event.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

Criteria

Inclusion Criteria:

• Age 18-80 years;

Histologically proven colorectal cancer

All the lesion (s) has been R0 resected

Have elevated tumor biomarker (CEA or CA19-9) in three consecutive tests

More than 1 CTC has been detected (including 1)

ECOG 0-1

Hematology tests suggest that they can tolerate chemotherapy

Written informed consent for participation in the trial

Exclusion Criteria:

• Have any radiological evidence of recurrence

Other previous malignancy within 5 years