NCT06101277

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a phase 2 pragmatic study at a single site 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 endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Conditions

• Esophageal Cancer
• Small Bowel Cancer
• Gastroesophageal-junction Cancer
• Gastric Cancer
• Colorectal Cancer
• Appendiceal Cancer
• Biliary Cancer
• Gall Bladder Cancer
• Intrahepatic Cholangiocarcinoma
• Extrahepatic Cholangiocarcinoma
• Oligoprogressive

Interventions

Type	Name	Description
DEVICE	Ablative local therapy	Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-12-05
• Completion: 2031-01-05
• First posted: 2023-10-26
• Last updated: 2025-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study