Partial liver transplantation for patients with colorectal liver metastases

Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma

This study is testing a new type of liver transplant for patients with colorectal cancer that has spread to the liver, to see if it can help them feel better when other treatments aren't an option.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Azienda Ospedaliera di Padova (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Padova)
• Trial ID: NCT04865471 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates an innovative approach to treating liver metastases through auxiliary liver transplantation. The procedure involves implanting a small liver graft after performing a left hepatectomy on the native liver, followed by a portal flow diversion to promote rapid regeneration of the transplanted liver segments. Patients selected for this trial must meet specific criteria, including having undergone prior treatment for their colorectal cancer and having limited lung metastases. The goal is to enhance liver function and improve outcomes for patients who are not candidates for traditional curative liver resection.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with histologically confirmed colorectal adenocarcinoma and limited liver metastases that are not amenable to curative resection.

Not a fit: Patients with extensive extrahepatic metastatic disease or those who do not meet the specific inclusion criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option for patients with liver metastases, potentially improving survival rates and quality of life.

How similar studies have performed: While this approach is innovative, similar studies in auxiliary liver transplantation have shown promise, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

* ≥ 18 and \<70 years
* Performance status, ECOG 0-1
* Histologically proved adenocarcinoma in colon or rectum
* BRAF wild-type CRC on primary tumor or liver metastases
* High standard oncological surgical resection of the primary tumor
* Liver metastases not eligible for curative liver resection confirmed by the validation committee
* At least one line (3 months) of chemotherapy
* At least 6 months time span from CRC resection and date of being listed on the transplantation list.
* At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
* No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have \<3 lung lesions all\<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
* Satisfactory blood tests creatinine in normal level, PLT \>60.000/mm3, GB\>2500/mm3
* CEA stable or in decrease
* Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

* Weight loss \>10% the last 6 months
* Patient BMI \> 30
* Participation refusal
* General contraindication to LT
* Other malignancies in the previous 5 years
* Pregnancy or breast feeding
* Any reason why, in the opinion of the investigator, the patient should not participate

Where this trial is running

Padova

• U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova — Padova, Italy (RECRUITING)

Study contacts

• Study coordinator: Umberto Cillo, MD

Conditions: Liver Metastases, Colorectal Liver Metastases, Auxiliary Liver Transplant