Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

Launched by UNIVERSITY OF CALIFORNIA, DAVIS · Oct 19, 2023

Keywords

ClinConnect Summary

The LIVELONG trial is a study designed to see if adding a special treatment called locally ablative therapy can help people with certain types of cancer who are already receiving systemic therapy (like chemotherapy). This trial focuses on patients with solid tumors that have a few new or growing spots (called oligo-progressive disease) in various areas, including the esophagus, stomach, and intestines. The main goal is to find out how long patients can continue their current treatment without needing to switch to something else after receiving the new therapy.

To participate in this trial, patients must be at least 18 years old and have one of the specified types of cancer. They should have already been receiving systemic therapy and must have shown some benefits from it for at least three months before new cancer spots appeared. Participants can expect to continue their current treatment while receiving the new locally ablative therapy, which targets specific areas of cancer. The trial is currently recruiting and aims to help improve treatment options for patients facing these challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Must have one of the following histologically and/or biochemically confirmed cancers:
• • 1. Cohort A: Esophageal, Gastroesophageal Junction, Gastric
• • 2. Cohort B: Small bowel
• • 3. Cohort C: Colorectal and appendiceal
• • 4. Cohort D: Biliary including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma
• • 5. Cohort E: Hepatocellular carcinoma
• • 6. Cohort F: Pancreatic and ampullary
• • 2. Provision of signed and dated informed consent form.
• • 3. Stated willingness to comply with all study procedures and availability for the duration of the study.
• • 4. Age ≥18 years at time of consent.
• • 5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
• • 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
• • 7. ≤ 5 progressing or new metastatic lesions.
• • 8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
• Exclusion Criteria:
• • 1. Medical comorbidities precluding locally ablative therapies.
• • 2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
• • 3. Progressing intracranial lesions.