Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06101277

Locally Ablative Therapy for Oligo-Progressive Gastrointestinal Cancers (LIVELONG) Phase 2 Study Evaluating Addition of Local Ablative Treatments to Systemic Therapy

Led by University of California, Davis · Updated on 2025-01-06

300

Participants Needed

1

Research Sites

378 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research focuses on patients with oligo-progressive solid tumors, including various gastrointestinal cancers such as esophageal, gastric, colorectal, biliary, and others. It evaluates whether continuing systemic therapy combined with locally ablative treatments can provide clinical benefit. The study is designed as a phase 2 pragmatic trial assessing disease control three months after ablative therapy, specifically looking for continued systemic therapy without changes or stopping treatment. Participants receive locally ablative therapies including stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation based on the treating physician's discretion, alongside their ongoing systemic cancer treatment. The study allows up to five years of follow-up after the initial ablative therapy to monitor outcomes. The treatments aim to target up to five progressing or new metastatic lesions safely treatable by these local methods. Throughout the study, participants will be closely monitored for disease control at three months post-ablative therapy, defined by continued systemic treatment without modification or discontinuation. Researchers will track the number of patients with controlled disease and overall time to treatment failure. To support safety and effectiveness assessments, participants must comply with all study procedures and remain available for the full study duration, ensuring comprehensive long-term data collection.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have one of these confirmed cancers: esophageal, gastroesophageal junction, gastric, small bowel, colorectal, appendiceal, biliary (including gallbladder and cholangiocarcinoma), hepatocellular carcinoma, pancreatic, or ampullary cancer
  • Be 18 years or older at the time of consent
  • Currently receiving systemic therapy and eligible to continue with no more than a 30-day planned break for local ablative therapy
  • Have received at least one line of systemic therapy for metastatic disease with at least 3 months of clinical benefit on the most recent therapy before new metastatic lesions appeared
  • Have no more than five progressing or new metastatic lesions
  • All progressing or new metastatic lesions must be safely treatable with locally ablative therapies as determined by the treating specialists
  • Provide signed and dated informed consent
  • Willing to comply with all study procedures and remain available for the study duration
Not Eligible

You will not qualify if you...

  • Have medical conditions that prevent use of locally ablative therapies
  • History of treatment-related toxicities that limit or prevent locally ablative therapies
  • Presence of progressing brain (intracranial) lesions

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of California, Davis

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

S

Selina Laqui

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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