Liver Transplant Technique for Colorectal Cancer

(CLEAR Trial)

Overseen By Yajaira Navarro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Pregnancy, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

Trial Summary

What is the purpose of this trial?

Liver transplantation (LT) has become an accepted treatment for selected patients with unresectable liver metastases due to colorectal cancer (CRLM). 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 staged vs. Two staged) used to perform a standard liver transplant procedure for recipients with CRLM. Investigators will look at things like different procedure results, recovery in the hospital, and survival rates one year after the transplant. Investigators will also take blood samples from participants to be used in future research. All the transplant methods the investigators are comparing are standard practices approved by the United Network of Organ Sharing (UNOS).

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 data supports the effectiveness of the treatment Resection And Partial Liver Transplantation With Delayed Total Hepatectomy for colorectal cancer?

Research shows that patients with colorectal cancer that has spread to the liver can live longer with surgical treatments like partial liver removal or liver transplantation. Studies indicate that these approaches can improve survival compared to just using chemotherapy, especially when the cancer cannot be fully removed by surgery alone. ^{1 2 3 4 5}

Is the RAPID liver transplant technique safe for humans?

The RAPID technique, which involves partial liver transplantation, is still experimental and has been performed in only a few cases worldwide. Preliminary results suggest it is technically feasible, but there is limited data on its long-term safety and outcomes. ^{6 7 8 9 10}

How is the RAPID treatment for colorectal cancer different from other treatments?

The RAPID treatment is unique because it involves a two-step liver transplant process where a small part of the liver is transplanted first, followed by the complete removal of the liver later. This approach aims to expand the donor pool and is still experimental, primarily used in clinical trials for patients with non-resectable liver tumors. ^{4 8 10 11 12}

Eligibility Criteria

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 can understand and agree to the study details on my own.

I am 18 or older, listed for a liver transplant at Northwestern due to colorectal cancer spread to my liver.

Exclusion Criteria

I am unable to give consent for medical procedures.

Pregnant women

Certain clinical/surgical/anatomical parameters at the discretion of the PI.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: RAPID- Deceased Donor Transplant Experimental Treatment 1 Intervention

RAPID-Deceased Donor Transplant

Group II: RAPID Living Donor Liver Transplant Experimental Treatment 1 Intervention

RAPID Living Donor Liver Transplant

Group III: Standard of Care/Conventional Living Donor Liver Transplant Active Control 1 Intervention

Standard of Care/Conventional Living Donor Liver Transplant

Group IV: Standard of Care/Conventional Deceased Donor Whole Liver Transplant Active Control 1 Intervention

Standard of Care/Conventional Deceased Donor Whole Liver Transplant

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

References

1. Greece pubmed.ncbi.nlm.nih.gov

Maximal debulking liver resection as a beneficial treatment strategy for advanced and aggressive colorectal liver metastases. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

A Novel Concept for Partial Liver Transplantation in Nonresectable Colorectal Liver Metastases: The RAPID Concept. [2015]

3. Canada pubmed.ncbi.nlm.nih.gov

Surgery as an alternative to chemotherapy for hepatic metastases from colorectal cancer. [2007]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Liver transplantation for non-resectable colorectal liver metastases: the International Hepato-Pancreato-Biliary Association consensus guidelines. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Hepatic resection of metastatic colorectal carcinoma: a ten-year experience. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Selective resection of colorectal liver metastases. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Simultaneous versus delayed hepatectomy for synchronous colorectal liver metastases: a systematic review and meta-analysis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Paradigm Shift in the Management of Irresectable Colorectal Liver Metastases: Living Donor Auxiliary Partial Orthotopic Liver Transplantation in Combination With Two-stage Hepatectomy (LD-RAPID). [2020]

9. England pubmed.ncbi.nlm.nih.gov

The results of surgery for colorectal hepatic metastases following expansion of the indications in 2005. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

RAPID procedure for colorectal cancer liver metastasis. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Simulated model of RAPID concept: highlighting innate inflammation and liver regeneration. [2021]

12. Japan pubmed.ncbi.nlm.nih.gov

Total robot-assisted recipient's surgery in living donor liver transplantation: First step towards the future. [2023]