NCT07885384|Not Yet RecruitingPhase 3
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Sponsor study identifier
interventional
140
0 countries
N/A
Study Start
October 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Colorectal cancer (CRC) is among the most common malignancies in China, and approximately half of all patients develop liver metastases. For patients with resectable or potentially resectable liver-only metastases, R0 metastasectomy followed by perioperative chemotherapy is the current standard. However, recurrence rates remain high, especially in patients with high recurrence risk. This phase III study investigates whether an additional 6 months of adjuvant extended therapy with the oral tyrosine kinase inhibitor fruquintinib combined with capecitabine improves disease-free survival compared with guideline-recommended observation, in patients who have completed R0 resection and at least 3 months of perioperative chemotherapy for liver-only metastatic CRC.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 24, 2026
Actual (reported)October 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 21, 2026
Actual (reported)April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
DFS1
Disease-free survival 1(DFS1), defined as the time from randomization until the first occurrence of loco-regional recurrence or distant metastasis (assessed by imaging, CT/MRI) or death from any cause.
From the date of randomization until the date of first documented loco-regional recurrence, distant metastasis (assessed by imaging, CT/MRI) or death from any cause, whichever occurs first, assessed up to 100 months.
DFS2
From the date of hepatic R0 surgery until the date of first documented tumor recurrence, metastasis (confirmed by imaging, CT/MRI) or death from any cause, whichever occurs first, assessed up to 100 months.
OS
From the date of randomization until the date of death from any cause, whichever occurs first, assessed by telephone every 6 months, up to 100 months.
Fruquintinib 3 mg PO QD D1-14, Q3W; Capecitabine 1000 mg/m² PO BID, Q3W; for up to 6 months
guideline-recommended surveillance
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Fruquintinib Combined With Capecitabine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordFirst Submitted
September 24, 2026
First Posted
October 21, 2026
Study Start
October 8, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 28, 2029
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 28, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 21, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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