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

Sponsored by University of California, Davis

About this trial

Last updated a year ago

Study ID

UCDCC308

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 3 years ago

What is this trial about?

This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

What are the participation requirements?

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.