Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here