Actively Recruiting
Locally Ablative Therapy for Oligo-Progressive Gastrointestinal Malignancies (LIVELONG)
Led by University of California, Davis · Updated on 2025-01-06
300
Participants Needed
1
Research Sites
265 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 aims to evaluate the clinical benefit of adding locally ablative therapies to ongoing systemic treatment in adults with oligo-progressive solid tumors, including various gastrointestinal cancers. The study focuses on patients who have experienced some clinical benefit from their current systemic therapy but have developed a limited number of new or progressing metastatic lesions. The primary goal is to assess the time to treatment failure and disease control following ablative local therapy. Participants will receive either stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy, chosen by their treating specialists. These ablative therapies are added to their existing systemic cancer treatment, which they will continue with no more than a 30-day planned break for the local therapy. The study includes a follow-up period of up to five years after the ablative treatment. During the study, participants will be monitored for disease control at three months after starting local therapy, as well as for any significant adverse events related to the ablative treatments. Researchers will also measure overall survival up to five years and time to treatment failure up to one year. Participants will undergo regular assessments as part of their ongoing cancer care and study follow-up to track outcomes and safety.
CONDITIONS
Brief Title
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or biochemically confirmed diagnosis of one of the following cancers: esophageal, gastroesophageal junction, gastric, small bowel, colorectal, appendiceal, biliary (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma), hepatocellular carcinoma, pancreatic, or ampullary cancer
- Signed and dated informed consent form
- Willingness to comply with all study procedures and available for study duration
- Age 18 years or older at time of consent
- Currently receiving systemic therapy and eligible to continue current line 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 most recent therapy before new metastatic lesions
- Have 5 or fewer progressing or new metastatic lesions
- All progressing or new metastatic lesions can be safely treated with locally ablative therapies as determined by treating specialists
You will not qualify if you...
- Medical conditions that prevent safely receiving locally ablative therapies
- History of treatment-related toxicities that limit or prevent use of locally ablative therapies
- Progressing intracranial lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days or as determined by treating specialists
Participants receive locally ablative therapy, including stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy, in addition to their ongoing systemic therapy.
1 to 2 visits depending on ablative therapy type
Duration - Up to 5 years following ablative local therapy
Participants are followed for clinical benefit, adverse events, and survival outcomes after ablative local therapy.
Periodic visits over up to 5 years
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
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