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New risk tool could predict cancer return after liver surgery

NCT ID NCT07391007

Knowledge-focused Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study aims to develop a system that combines genetic and clinical data to predict which patients with colorectal cancer that has spread to the liver are at high risk of the cancer coming back after surgery. Researchers will study 200 adults aged 18-75 who have had complete removal of both the colon tumor and liver metastases. The goal is to use this risk information to guide personalized decisions about whether additional chemotherapy after surgery would be helpful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients were diagnosed with resectable colorectal liver metastases

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Aged 18 to 75 years, inclusive (male or female). 2. Pathologically and radiologically confirmed colorectal cancer with liver metastases. 3. Must have undergone complete (R0) surgical resection of both the primary colorectal tumor and all liver metastases. 4. Have adequate organ function and no contraindications to potential adjuvant therapies (surgery, chemotherapy, radiotherapy, immunotherapy). 5. Willing and able to comply with the study protocol and follow-up visits. 6. Availability of sufficient liver metastasis tumor tissue for gene sequencing. 7. Provision of a blood sample for circulating tumor DNA (ctDNA) detection within one month after surgery but before starting any adjuvant therapy. Exclusion Criteria: 1. Pregnancy or breast-feeding women 2. History of other malignancies within 5 years (except cured skin cancer and cervicalcancer in situ) 3. History of uncontrolled epilepsy, central nervous system disease, or psychiatricdisorders 4. Clinically serious heart disease, such as symptomatic coronary artery disease, NewYork Heart Association (NYHA) class II or worse congestive heart failure or severearrhythmia requiring pharmacologic intervention, or history of myocardial infarctionwithin the last 12 months 5. Baseline blood and biochemical indicator do not meet the following criteria:neutrophils \>=1.5×10\^9/L, Hb \>=90g/L, PLT \>=100×10\^9/L, ALT/AST\<=2.5 ULN, Cr \<= 1ULN 6. Allergic to any component of the therapy 7. Severe uncontrolled recurrent infections

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal liver metastases

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

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