Randomized Trial of Plasma ctDNA Methylation-Guided Adjuvant Therapy in T4N0 and Low-Risk Stage III Colorectal Cancer

Recruiting Phase 2 Interventional Study
ctDNA Colorectal Cancer Chemotherapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
340 (estimated)
Sponsor
Fudan University · Other
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About This Trial
The patient (T4N0 or low-risk stage III) will be randomly assigned to either the control group (FOLFOX/CAPOX for 3 months) or the intervention group (FOLFOX/CAPOX for 6 months or FOLFOX/CAPOX for 3 months followed by FOLFIRI/CAPIRI for 3 months) to receive adjuvant therapy. Venous blood samples (8-16 mL) will be collected at 1 month, 3 months, and 6 months after surgery for dynamic monitoring of p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years, regardless of sex; 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, with an expected survival of \>3 months; 3. Histologically confirmed postoperative pTNM stage high-risk stage II colorectal cancer; 4. Positive ctDNA status at 1 month af…
Contacts

Guoxiang Cai

86-18017312703

gxcaifuscc@163.com

CONTACT