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

Trial Details

Sponsor: University of California, Davis (other)

Phase: NA

Start date: Oct. 5, 2023

Planned enrollment: 300

Trial ID: NCT06101277

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More trial details at ClinicalTrials.gov

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Investigational Drug AI Analysis

No investigational drugs.

HealthScout AI Analysis

Goal: Evaluate whether adding locally ablative therapy to treat oligo-progressive lesions allows patients with metastatic gastrointestinal malignancies to continue their current systemic therapy and achieve short-term disease control, and to characterize safety and survival outcomes.

Patients: Adults with metastatic gastrointestinal cancers (esophageal/GEJ/gastric; small bowel; colorectal/appendiceal; biliary tract including gallbladder and cholangiocarcinoma; hepatocellular carcinoma; pancreatic/ampullary) who are on an active line of systemic therapy with at least 3 months of clinical benefit, have developed up to 5 new or progressing metastatic lesions amenable to local ablation, and are candidates to continue the same systemic regimen with at most a 30-day treatment break. Excludes those with contraindications to local ablation or progressing intracranial disease.

Design: Single-site, phase 2 pragmatic, non-randomized study enrolling approximately 300 participants. All eligible patients receive protocol-directed local ablative therapy while continuing their current systemic regimen. Follow-up extends up to 5 years after local therapy.

Treatments: Locally ablative therapy delivered as stereotactic ablative radiotherapy (SABR) or interventional radiology ablation, selected at the discretion of the treating radiation oncologist or interventional radiologist, in addition to the patient’s ongoing standard systemic therapy. These are established standard local modalities intended to eradicate limited sites of progression while maintaining systemic control.

Outcomes: Primary: Disease control at 3 months, defined as continuation of the same systemic therapy without changes or permanent discontinuation for 3 months following the first day of ablative therapy. Secondary: Grade ≥3 adverse events attributable to the ablative therapy (through 2 years), median overall survival stratified by tumor type (through 5 years), and time to treatment failure defined as time to systemic therapy change or permanent discontinuation (through 1 year).

Burden on patient: Moderate. Patients undergo one or more ablative procedures (SABR delivered over a few fractions or a percutaneous IR ablation), with associated visits, imaging for planning and response assessment, and potential short-term treatment break of up to 30 days. No intensive pharmacokinetic sampling or mandatory biopsies are specified. Follow-up includes routine clinical assessments and imaging over several years, similar to standard metastatic care, but adds procedure-related appointments and possible toxicities management, increasing visit frequency around the time of local therapy.

Eligibility

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