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AzTrials

OncologyNCT06934018

Effect of Surgical Margin Width on Recurrence and Survival in Patients With Hepatic Oligometastasis of Colorectal Cancer

A study testing Surgery and procedure in people with Oncology and Tumor Recurrence and Metastasis, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oncology, Tumor Recurrence and Metastasis
What is being tested?
Surgery and procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteChina
Study dates
21 Apr 2025to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients, age ≥18 years;
  • ECOG Physical condition score :0-1 score;
  • Liver biopsy pathologic diagnosis or clinical history combined with laboratory examination and imaging findings can be used to diagnose colorectal cancer in liver;
  • The primary lesion of colorectal cancer has been resected or can be resected 4-6 weeks after hepatectomy;
  • The number of liver metastases was less than or equal to 5；
  • There was no extrahepatic metastases or the metastases were radically resected；
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  • Preoperative assessment (based on enhanced CT or MRI image AI segmentation combined with three-dimensional reconstruction of hepatic parenchymal blood vessels) enables radical (R0) resection of hepatic oligometastases, and wide surgical margin (the narrowest incisal margin of fresh specimens surgically removed is greater than or equal to 7mm) can be achieved technically, and the incisal margin width is not affected by the intrahepatic vasculature；
  • Good liver reserve function (preoperative Child-Pugh grade A liver function, estimated remaining liver volume ≥30%)；
  • Preoperative examinations do not show clear surgical contraindications；
  • Volunteer to participate in this study and sign the informed consent；
  • The compliance was good, and the family members were willing to cooperate with the follow-up；

Who cannot join

  • There are still untreated extra-hepatic metastases；
  • Staging hepatectomy is planned, such as PVE combined with hepatectomy, ALPPS, etc；
  • The number of liver metastases before chemotherapy was more than 5；
  • Complicated with portal vein tumor thrombus or hepatic vein invasion；
  • Concurrent with other uncured malignancies or with other primary malignancies for less than 5 years；
  • Expected survival time ≤6 months；
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  • Those who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders；
  • Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases; Or have an autoimmune disease；
  • According to the study, there are serious concomitant diseases that endanger the patient's safety or interfere with the patient's completion of the study；
  • Patients or family members could not understand the conditions and goals of the study；

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lu Wang, PhD contact

+8613601678615

w.lr@hotmail.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200062

    Lu Wang, M.D., +8613601678615, w.lr@hotmail.com

    Recruiting

Other trials in China

About this study

The main objective of this study was to evaluate the effect of surgical margin width on the prognosis of patients with hepatic oligometastasis of colorectal cancer by statistical 1-year intrahepatic recurrence-free survival rate (ihRFSrate). The secondary objective of the study was to evaluate the effect of surgical margin width on long-term survival and total recurrence of colorectal cancer in patients with hepatohepatic metastasis by statistical overall survival time (OS) and relapse-free survival time (RFS), and to evaluate the safety of wide margin surgery compared with narrow margin surgery in patients with Cromitis during perioperative period.

This was a single-center, prospective, randomized controlled clinical study to evaluate the effects of surgical margin width on 1-year intrahepatic relapse-free survival, relapse-free survival time, overall survival time, and perioperative safety in patients with hepatic oligometastasis of colorectal cancer. Subjects will undergo radical resection of liver tumors and will be randomly assigned to a wide margin group (≥7mm) or narrow margin group (<7mm) using stratified randomization, stratified by primary lesion site (right colon vs left colon/rectum). The margin width was the narrowest margin distance measured in fresh specimens. After radical liver tumor resection, subjects were pretreated regularly Follow-up evaluation.

Being tested
Surgery and procedure
Keywords
Liver metastasis of colorectal cancer
Medical subject headings
Neoplasms, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgery and procedureProcedure or surgery

    According to the "Chinese Guidelines for the Diagnosis and Comprehensive Treatment of Liver metastases of Colorectal Cancer (2023 edition)", R0 resection of metastatic tumors is satisfied, and the objective is to preserve sufficient functional liver tissue, and the surgical margin width is less than 7mm

  • Surgery and procedureProcedure or surgery

    Combined with intraoperative B-ultrasound guidance, 3D reconstruction and intraoperative navigation, the surgical margin width of metastatic tumor was greater than or equal to 7mm

Study groups in NCT06934018
Study groupRoleWhat they receive
Experimental groupExperimentalThe surgical margin width was greater than or equal to 7mm
Receives: Procedure: Surgery and procedure
Control groupExperimentalThe surgical margin width was less than 7mm
Receives: Procedure: Surgery and procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intrahepatic recurrence-free survival at 1 year(ihRFS rate)

    Refers to the percentage of subjects in this group who received intrahepatic imaging diagnosis of recurrence or death from any cause from surgery to 1 year after surgery.

    Measured: From liver tumor resection to 1 year after surgery

Secondary outcomes (3)

  1. Recurrence free survival time(RFS)

    The earliest date from the date of receipt of liver tumor resection to the date of confirmation of tumor recurrence or the date of death from any cause. Regular follow-up visits were conducted until the end of the study follow-up

    Measured: 12 months

  2. Overall survival time(OS)

    Refers to the time from liver tumor resection to death from any cause, if the above criteria were not met, the date of the last evaluation was used for analysis.

    Measured: 24 months

  3. Perioperative safety

    In this study, the incidence of perioperative complications was calculated according to Clavien Dindo complication scoring system. At the same time, perioperative death, operative time, intraoperative blood loss, blood transfusion and other surgical safety treatment were counted

    Measured: Patient 90 days after hepatectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2025
  2. Study start21 Apr 2025
  3. Primary completion7 Apr 2026 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06934018
Sponsor's protocol ID
2503317-21
Status last verified
May 2025
First submitted
9 Apr 2025
Last updated
6 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Weichselbaum RR, Hellman S. Oligometastases revisited. Nat Rev Clin Oncol. 2011 Jun;8(6):378-82. doi: 10.1038/nrclinonc.2011.44. Epub 2011 Mar 22.

    PubMed 21423255

  • Su YM, Liu W, Yan XL, Wang LJ, Liu M, Wang HW, Jin KM, Bao Q, Wang K, Li J, Xu D, Xing BC. Five-year survival post hepatectomy for colorectal liver metastases in a real-world Chinese cohort: Recurrence patterns and prediction for potential cure. Cancer Med. 2023 Apr;12(8):9559-9569. doi: 10.1002/cam4.5732. Epub 2023 Feb 27.

    PubMed 36846977

  • Laroche S, Scatton O, Charlotte F, Bachet JB, Lim C, Fuks D, Goumard C. Prognosis of a Heterogeneous TRG Pathological Response to Neoadjuvant Chemotherapy in Patients who Undergo Resection for Colorectal Liver Metastases. Ann Surg Oncol. 2024 Jul;31(7):4436-4444. doi: 10.1245/s10434-024-15196-x. Epub 2024 Mar 28.

    PubMed 38549003

  • Guckenberger M, Lievens Y, Bouma AB, Collette L, Dekker A, deSouza NM, Dingemans AC, Fournier B, Hurkmans C, Lecouvet FE, Meattini I, Mendez Romero A, Ricardi U, Russell NS, Schanne DH, Scorsetti M, Tombal B, Verellen D, Verfaillie C, Ost P. Characterisation and classification of oligometastatic disease: a European Society for Radiotherapy and Oncology and European Organisation for Research and Treatment of Cancer consensus recommendation. Lancet Oncol. 2020 Jan;21(1):e18-e28. doi: 10.1016/S1470-2045(19)30718-1.

    PubMed 31908301

Questions about this trial

What is this clinical trial studying?

A study testing Surgery and procedure in people with Oncology and Tumor Recurrence and Metastasis, run by Fudan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lu Wang, PhD (+8613601678615, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intrahepatic recurrence-free survival at 1 year(ihRFS rate) (time frame: From liver tumor resection to 1 year after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06934018, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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