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NCT02597348

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases Treated by Chemotherapy

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

Official title: Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2016-02

Completion Date

2026-07

Last Updated

2024-02-14

Healthy Volunteers

Conditions

Liver Metastasis Colorectal Cancer Metastasis

Interventions

PROCEDURE

Liver Transplantation

The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .

Inclusion Criteria: * ≥ 18 and ≤ 65 years * Good performance status, ECOG 0 or 1 (39). * 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 defined by : * Safe margin of resection * Curative resection of primary tumor according to oncological principles * TNM adequate staging * Absence of local recurrence on colonoscopy performed in the 12 months prior to inclusion (except in case of primary tumor resection \< 12 months ) * Confirmed non resectable colorectal liver metastases by the validation committee * ≥ 3 months of tumor control during the last chemotherapy line: Stable or Partial Response on RECIST criteria (40) * ≤ 3 lines of chemotherapy for metastatic disease * CEA \< 80 microg/L or a decrease ≥ 50% of the highest serum CEA levels observed during the disease * Absence of extrahepatic tumor localisation according to CT scan and PET-CT * Renal function should be within the normal limits * No need for extra-renal purification procedure, hemodialysis or kidney transplantation associated (nephrologist assessment) * A platelet count\> 80,000 / mm3 * White blood cell count\> 2500 / mm3 * Eligible for both treatments groups * Signed informed consent and expected cooperation of the patient for the treatment and follow up Exclusion Criteria: * Participation refusal * No health insurance facilities * General contraindication to LT (Severe cardiopulmonary disease or other life-limiting coexisting medical conditions, extrahepatic malignancy, active alcohol or substance abuse, active infection or uncontrolled sepsis, lack of psychosocial support or inability to comply with medical treatment) * Other malignancies either concomitant or within 5 years before liver transplantation * Patients not having received standard treatment for the primary CRC according to recommended guidelines * Prior extra hepatic metastatic disease or local relapse * Pregnancy at the time of inclusion

Locations (1)

AP-HP, Paul Brousse Hospital

Villejuif, France