EXtended CriteriA Treatment for LIver Metastases and Heavy Tumour BURden

• Status: Recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with multiple colorectal liver metastases that progress on 1st line chemotherapy have a very dismal prognosis, and their options are few. Resections are regularly performed although this is only supported by anecdotal evidence for this patient group. We want to assess whether resections actually confer benefit as compared to 2nd line chemotherapy alone, in a randomized controlled trial.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oslo University Hospital

Criteria

Inclusion Criteria:

1. Verified adenocarcinoma in colon or rectum

2. Liver metastases that are technically resectable (ablation can be used as an adjunct) without PVE, HVE or ALPPS, but judged in need of further (next line) chemotherapy based on insufficient response to at least one line of chemotherapy. And either

a. Six or more liver metastases, with extra-hepatic disease i. def: >3 pulmonary metastases/radiologically positive non-liver hilar lymph nodes. Or b. Ten or more liver metastases with at least one of the following negative prognostic signs: i. At least one lesion > 7 cm in diameter before chemotherapy ii. CEA > 100 following a full cycle of chemotherapy)?? iii. KRAS and/or BRAF mutant primary tumour. iv. Node positive primary tumour. Or c. Fifteen or more liver metastases

3. ECOG 0/2

4. Informed consent

Exclusion Criteria:

Any of the following criteria will exclude participation in the trial:

1. New liver metastases emerging during completed chemotherapy.

a. These patients may be included if they undergo a complete cycle of next line chemotherapy without new liver metastases emerging.

2. Previous or current bone or CNS metastatic disease

3. Any other reason why, in the opinion of the investigators, the patient should not participate.

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