March 2025

ORGAN TRANSPLANT

PROGRAM IMPROVES LIVER TRANSPLANT ACCESS FOR PATIENTS WITH STAGE 4 COLORECTAL CANCER

Featuring: Satish Nadig, MD, PhD and Zachary Dietch, MD 

The challenge of organ allocation for liver transplantation remains a critical concern for physicians treating patients with stage 4 colorectal cancer (CRC) who present with liver metastases. This demographic faces unique barriers due to the limited availability of donor organs and the nuances of the transplantation allocation system.
To address these challenges, Northwestern Medicine has launched a clinical program called Colorectal Metastasis to Liver Extraction with Auxiliary Transplant and Delayed Resection (CLEAR). This program aims to provide innovative care for patients diagnosed with advanced colorectal cancer and liver metastases.

Program Overview and Surgical Innovation

Under the CLEAR Program, surgeons at Northwestern Medicine have successfully used a technique known as resection and partial liver transplantation with delayed total hepatectomy (RAPID). This two-stage surgical approach allows for the effective use of deceased-donor livers through an innovative split-liver strategy, enabling a portion of the liver to be transplanted to a patient with advanced disease who doesn’t have access to a suitable living donor.

​Satish Nadig, MD, PhD, director of the Northwestern Medicine Comprehensive Transplant Center, highlights the unmet need within this patient population: “The current organ allocation system does not adequately prioritize patients with CRC and liver metastases, often relegating them to the lower tiers of the wait list. As a result, many patients only receive palliative care, which is insufficient given the potential for curative interventions through transplantation.”

A Case Study

The first patient to benefit from this innovative approach was a 53-year-old male whose liver was severely compromised due to stage 4 colorectal cancer that had metastasized to the liver. The medical team slowed the progression of the disease with chemotherapy, a colon resection and liver ablations, but the cancer grew resistant to treatment. They had also exhausted all living organ donation candidates. Traditional transplantation would have required an extensive wait time.
In October 2024, a 57-year-old female patient with a higher MELD score matched with a donor after cardiac death (DCD) liver and agreed to share a piece of the liver that had been allocated to her with the male patient.

Surgeons removed a small, left lateral graft from the donor liver while the organ was on machine perfusion. The larger portion was then transplanted into the female patient.
Surgeons removed the cancerous liver mass from the male patient while implanting the graft into the remaining hepatic tissue.

The patient waited two weeks, giving the graft time to mature to nearly double the size, then a subsequent resection eliminated the remaining cancerous liver tissue.
Four months post-transplant, the patient showed no signs of cancer recurrence and no need for additional cancer therapy. The female patient also had good outcomes and was recovering normally.
 
“This procedure is incredibly rare and involves many moving parts,” says Dr. Nadig. “RAPID has been sparingly utilized outside of America, but by splitting a DCD liver on a machine perfusion pump, we’ve chosen to apply it in a unique way at Northwestern Medicine.”

Clinical Implications and Future Directions

“We are excited to offer RAPID as an option through the CLEAR program,” says Transplant Surgeon Zachary Dietch, MD. “Data reveals that without transplantation, the five-year survival rate for patients with liver metastasis from colorectal cancer is 10%, in contrast to the 80% survival rate achievable through successful liver transplantation when the malignancy is confined to the liver.”

Continued research through the program will track the outcomes of the initial cohort of 80 patients via a research registry also called CLEAR, available on clinicaltrials.gov. This data will be pivotal in refining selection criteria, enhancing surgical techniques and improving overall patient care.

The CLEAR Program emphasizes the importance of integrating expertise from oncology, transplant surgery and organ recovery, researchers and physicians can navigate the complexities of treating advanced colorectal cancer with innovative solutions.
As the field evolves, further exploration of biomarkers, genetic profiling and patient stratification will be essential.

About the CLEAR Research Registry

The outcomes of the CLEAR program’s first 80 patients will be tracked in a research registry available on ClinicalTrails.gov. Participation in the research registry is voluntary. A patient may receive a RAPID transplant as part of the CLEAR program without enrolling in the CLEAR research registry. 
“It is still early, but accumulated evidence that shows that certain patients with cancer who receive transplants will derive equivalent or better outcomes than patients who receive transplants for more traditional indications,” says Dr. Dietch. “Transplant oncology is a new frontier in the field of transplant, and Northwestern Medicine is at the forefront.”
Satish N. Nadig, MD, PhD, is director of the Comprehensive Transplant Center, chief of Organ Transplantation in the Department of Surgery, and the Edward G. Elcock Professor of Surgical Research at Northwestern Medicine.
Zachary Dietch, MD is a transplant surgeon and assistant professor, of organ transplantation in the Department of Surgery at Northwestern Medicine.

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