NCT07919951Not yet recruiting
RAPID for Unresectable Colorectal Liver Metastases
Efficacy of the RAPID Procedure (Resection and Partial Liver Transplantation With Delayed Total Hepatectomy) for Unresectable Colorectal Liver Metastases: A Prospective Clinical Study
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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: 1. How many participants are alive without the cancer progressing or returning 2 years after the first-stage surgery? 2. How many participants complete the second-stage surgery, and how quickly does the liver graft grow between the two stages? 3. What medical problems do participants have around the time of surgery, including serious complications? Participants will: 1. Undergo the first-stage surgery: removal of the left part of the liver and implantation of a small liver graft, with the right portal vein tied off to help the graft grow; 2. Have blood tests and ultrasound checks after surgery, and regular CT or MRI scans to measure graft growth; (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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 31 Oct 2026
- Start date
- 30 Dec 2026
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07919951
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 30 Dec 2026 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Primary colorectal tumor not amenable to radical resection.
- Prior solid organ transplantation; HIV infection.
Other illness
- Severe hepatic insufficiency (Child-Pugh class B or C), or clinically significant portal hypertension.
- Severe cardiopulmonary or renal insufficiency, or judged by the surgeon to be unable to tolerate two-stage major surgery.
- Other malignancy diagnosed within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).
Other
- Unresectable extrahepatic metastases (resectable pulmonary nodules are permitted).
- BRAF V600E mutation or microsatellite instability-high (MSI-H).
- Pregnant or breastfeeding women, or women planning pregnancy during the study
Who the study is looking for
- Age 18 to 65 years; ECOG performance status 0 to 1.
- Histologically confirmed colorectal adenocarcinoma; primary tumor radically resected, or resectable synchronously or in a staged manner.
- Unresectable colorectal liver metastases as assessed by a multidisciplinary team (hepatobiliary surgery, medical oncology, radiology).
- No unresectable extrahepatic metastases.
- Received standard chemotherapy plus targeted therapy, with stable disease.
- BRAF V600E wild-type and microsatellite stable (MSS).
- Child-Pugh class A, without clinically significant portal hypertension.
- Signed written informed consent and able to comply with the protocol and follow-up.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.