ctDNA-guided Adjuvant Chemotherapy in Liver Metastasis of Colorectal Cancer
Recruiting
Phase 3
Interventional Study
Colorectal Cancer
Liver Metastases
Circulating Tumor Cell
Chemotherapy Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 490 (estimated)
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University · Other
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About This Trial
The goal of this clinical trial is to compare in resectable colorectal cancer liver metastasis patients.The main question it aims to answer is whether the 3-year progression-free survival rate (PFS) of "watching and waiting" is non-inferior to adjuvant chemotherapy in postoperative ctDNA-negative resectable colorectal cancer liver metastasis patients.Participants will undergo ctDNA testing after r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Both genders are eligible; aged between 18-75 years old; have received neoadjuvant chemotherapy;
2. Patients with liver metastatic colorectal cancer who have achieved R0 resection according to MDT evaluation (including patients with metastases treated with ablation therapy th…
Contacts
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