An interventional study of RAPID Procedure in Colorectal Liver Metastases (CRCLM) and Colorectal Neoplasms, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if the RAPID procedure works to treat colorectal cancer that has spread to the liver and cannot be removed by surgery. It will also learn about the safety of the procedure. The main questions it aims to answer are:
Participants will:
(4) Undergo the second-stage surgery to remove the remaining diseased liver once the graft has grown enough (5) Visit the clinic every 3 months for up to 2 years after the second-stage surgery for checkups, imaging, and blood tests to see if the cancer has returned
This is a prospective clinical trial evaluating the RAPID procedure (Resection and Partial Liver Transplantation with Delayed Total Hepatectomy) in patients with unresectable colorectal liver metastases (uCRLM).
Stage 1 is performed on Day 0: partial hepatectomy is carried out to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support. A small-for-size graft is implanted orthotopically. The portal vein supplying the preserved native liver is ligated to redirect portal flow to the graft, while the hepatic artery supplying the preserved native liver is preserved.
Interstage monitoring begins on postoperative Day 1. Liver function (TBIL, INR, ALT, AST) and graft blood flow (Doppler ultrasound) are assessed. Graft volume is measured by CT/MRI volumetry on postoperative Days 7 and 14, and every 7 days thereafter. The criteria for proceeding to Stage 2 (all must be met) are: graft GRWR ≥0.8%, and multidisciplinary team (MDT) confirmation that Stage 2 surgery can proceed. The first formal assessment is on postoperative Day 7.
Stage 2 is performed once the criteria are met: the remnant native liver is removed, and the graft is preserved.
Postoperative follow-up continues for up to 2 years after Stage 2 (with exploratory extension to 5 years), with visits every 3 months. Assessments include history and physical examination, ECOG status, liver function, CEA/CA19-9, contrast-enhanced CT of the chest and abdomen. Tumor progression or recurrence is adjudicated by an independent imaging reviewer. The primary endpoint is the 2-year tumor event-free survival rate, defined as the time from Stage 1 surgery to tumor progression, recurrence, or death from any cause, whichever occurs first.
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6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 10 is below the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 483 studies on the registry; 283 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled participants receive the RAPID procedure, a two-stage surgical intervention. Stage 1: partial hepatectomy to remove the tumor-bearing portion of the liver, preserving the remaining native liver as temporary metabolic support; orthotopic implantation of a small-for-size liver graft; ligation of the portal vein supplying the preserved native liver to redirect portal flow to the graft, with preservation of the hepatic artery supplying the preserved native liver. Stage 2: completion hepatectomy to remove the remnant native liver after adequate graft hypertrophy (graft GRWR ≥0.8% and MDT confirmation).
Procedure: RAPID Procedure
Two-stage surgical procedure combining the principles of ALPPS with auxiliary partial liver transplantation. Stage 1 (Day 0): partial hepatectomy to remove the tumor-bearing liver portion, orthotopic implantation of a small-for-size graft (living donor left lateral segments or split deceased-donor left lateral segments), and ligation of the portal vein supplying the preserved native liver; the corresponding hepatic artery is preserved. Interstage monitoring includes liver function tests, Doppler ultrasound, and CT/MRI volumetry. Stage 2: completion hepatectomy of the remnant native liver once the graft has achieved adequate volume and function.
2-Year Tumor Event-Free Survival Rate
Proportion of participants alive and free of tumor progression or recurrence at 2 years after Stage 1 surgery. A tumor event is defined as tumor progression or recurrence confirmed by imaging (CT/MRI/PET-CT) according to RECIST 1.1 or by pathology, or death from any cause, whichever occurs first. Participants who fail to complete Stage 2 surgery are counted as having an event from the date of Stage 2 failure, regardless of whether tumor progression has occurred. Participants last known to be alive and event-free are censored at the date of last follow-up.
Time frame: From Stage 1 surgery to tumor progression, recurrence, or death from any cause, assessed up to 2 years after Stage 1 surgery
Incidence of Major Perioperative Complications (Clavien-Dindo Grade ≥IIIa)
Proportion of participants experiencing Clavien-Dindo grade ≥IIIa complications from Stage 1 surgery through 90 days after Stage 2 surgery. Grade IIIa indicates complications requiring surgical, endoscopic, or radiological intervention without general anesthesia; grade IIIb requires intervention under general anesthesia; grade IV indicates life-threatening organ dysfunction requiring ICU management; grade V indicates death. Complications are recorded by type (e.g., primary graft non-function, small-for-size syndrome, biliary complications, vascular complications, bleeding, infection, renal failure requiring replacement therapy, respiratory failure requiring mechanical ventilation).
Time frame: From Stage 1 surgery through 90 days after Stage 2 surgery
Stage 2 Completion Rate
Proportion of participants who successfully complete Stage 2 completion hepatectomy among all participants who undergo Stage 1 surgery. The decision to proceed to Stage 2 is made by the multidisciplinary team based on graft volume growth (target GRWR ≥0.8% or graft volume doubling) and recovery of liver function. Participants who do not proceed to Stage 2 by Day 42 after Stage 1, or who discontinue the surgical pathway due to tumor progression or persistent graft dysfunction, are counted as not completing Stage 2.
Time frame: From Stage 1 surgery until Stage 2 completion or up to Day 42 after Stage 1 surgery
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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