80 Participants Needed

Liver Transplant Technique for Colorectal Cancer

(CLEAR Trial)

YN
Overseen ByYajaira Navarro
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwestern University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different liver transplant techniques for individuals with colorectal cancer that has spread to the liver. It compares patient recovery and survival using various approved transplant methods, such as those from living or deceased donors and whole or split livers. Researchers aim to determine which approach benefits patients most in terms of hospital recovery and one-year survival. Individuals diagnosed with colorectal cancer that has spread to the liver and are already listed for a liver transplant may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these liver transplant techniques are safe for colorectal cancer patients?

Research has shown that the RAPID procedure, which stands for "Resection and Partial Liver Transplantation With Delayed Total Hepatectomy," is under study as a treatment for liver tumors from colorectal cancer. This procedure aims to increase the availability of liver transplants and improve survival rates for patients with these liver conditions.

In related studies, researchers have used the RAPID technique in patients with advanced colorectal cancer that has spread to the liver. Although the safety of this procedure in humans is still under investigation, its inclusion in a trial suggests promise based on earlier research. However, current sources do not provide detailed information on side effects or patient tolerance.

This study compares different liver transplant methods, including the RAPID technique. All transplant methods under study are standard practices approved by the United Network of Organ Sharing (UNOS), indicating they are generally considered safe and effective based on past data. However, as with any medical procedure, especially transplants, potential risks exist, and individual responses may vary.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative liver transplant techniques specifically for colorectal cancer patients. Unlike traditional methods that typically involve whole liver transplants from a deceased donor, this trial investigates resection and partial liver transplantation with a delayed total hepatectomy. The RAPID technique, using either deceased or living donors, aims to offer more flexibility and potentially increase the availability of suitable organs for patients. By refining these approaches, the trial hopes to improve outcomes and expand treatment options for individuals battling colorectal cancer with liver metastases.

What evidence suggests that this trial's liver transplant techniques could be effective for colorectal cancer?

Studies have shown that liver transplants can lead to good survival rates for patients with colorectal cancer that has spread to the liver, particularly for certain patients. The RAPID procedure, which involves dividing a liver for transplant, is being tested in this trial in two separate arms: one using a deceased donor and another using a living donor. This method aims to improve survival rates. Surgery to remove the cancer is the only potential cure for patients with cancer spread to the liver, but it's only possible for 10–20% of patients. Therefore, the RAPID approach could help more patients by increasing the availability of liver transplants and improving outcomes. These findings suggest that liver transplant techniques, including the RAPID method, can effectively treat this type of cancer.23467

Are You a Good Fit for This Trial?

This trial is for patients with colorectal cancer that has spread to the liver and cannot be removed with surgery alone. Candidates must not have had previous liver transplants or other treatments that would exclude them from a partial transplant followed by delayed total hepatectomy.

Inclusion Criteria

I am 18 or older, listed for a liver transplant at Northwestern due to colorectal cancer spread to my liver.
I can understand and agree to the study details on my own.

Exclusion Criteria

Pregnant women
I am unable to give consent for medical procedures.
Certain clinical/surgical/anatomical parameters at the discretion of the PI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo liver transplantation using various approved methods (living vs. deceased, whole organ vs. split, one staged vs. two staged)

Hospital recovery period

Follow-up

Participants are monitored for graft and patient survival outcomes, as well as complications or surgical outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Resection And Partial Liver Transplantation With Delayed Total Hepatectomy
Trial Overview The CLEAR Trial is testing a technique called RAPID, which involves staged liver resections combined with a partial liver transplant, followed later by complete removal of the liver, in patients whose colorectal cancer has metastasized to the liver.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Active Control
Group I: RAPID- Deceased Donor TransplantExperimental Treatment1 Intervention
Group II: RAPID Living Donor Liver TransplantExperimental Treatment1 Intervention
Group III: Standard of Care/Conventional Living Donor Liver TransplantActive Control1 Intervention
Group IV: Standard of Care/Conventional Deceased Donor Whole Liver TransplantActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/32302748/
RAPID procedure for colorectal cancer liver metastasisLiver transplantation for colorectal cancer has regained renewed interest with reported good overall survival in selected patients.
Resection and Partial Liver Transplantation With Delayed ...In RAPID, our surgeons split a liver into two parts. They transplant one part into the intended recipient and the smaller part into a patient with ...
RAPID procedure for colorectal cancer liver metastasisAbout 50% of the patients develop liver metastases (CRLM), and the only potential curative treatment option is liver resection, but only 10–20% of the patients ...
NCT06698146 | Colorectal Metastasis to Liver Extraction ...The goal of this study is to look at and compare the clinical results of all the different approved methods (living vs. Deceased, whole organ vs. Split, one ...
Resection and partial liver transplantation from deceased ...This trial wants to ascertain whether the RAPID procedure could improve graft availability and patient survival in hepatocellular carcinoma (HCC) setting.
Resection and partial liver transplantation from deceased ...This trial wants to ascertain whether the RAPID procedure could improve graft availability and patient survival in hepatocellular carcinoma ...
Q&A with Dr Satish Nadig: Novel RAPID technique ' ...Dr Satish Nadig describes Northwestern Medicine's first use of the RAPID procedure to treat metastatic colorectal cancer with liver ...
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