Combining local therapy with ongoing systemic treatment for certain cancers

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

This study is testing whether adding local treatments to ongoing systemic therapy can help people with certain cancers keep their disease under control for longer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, Davis (other)
• Drugs / interventions: radiation
• Locations: 1 site (Sacramento, California)
• Trial ID: NCT06101277 on ClinicalTrials.gov

What this trial studies

This phase 2 pragmatic study evaluates the benefits of continuing systemic therapy while adding locally ablative therapies for patients with oligo-progressive solid tumors. The primary goal is to measure disease control at 3 months, defined as the ability to continue systemic therapy without changes or permanent discontinuation after receiving local ablative therapy. Participants will receive either stereotactic ablative radiotherapy or interventional radiology ablation therapy, depending on the discretion of their treating specialists. The study will follow participants for up to 5 years to assess long-term outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed diagnoses of esophageal, gastric, colorectal, or other specified cancers who are currently on systemic therapy.

Not a fit: Patients who have not responded to systemic therapy or those with rapidly progressing disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve disease control and prolong the effectiveness of systemic therapies for patients with specific types of cancer.

How similar studies have performed: Other studies have shown promise in combining local ablative therapies with systemic treatments, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Must have one of the following histologically and/or biochemically confirmed cancers:

   1. Cohort A: Esophageal, Gastroesophageal Junction, Gastric
   2. Cohort B: Small bowel
   3. Cohort C: Colorectal and appendiceal
   4. Cohort D: Biliary including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma
   5. Cohort E: Hepatocellular carcinoma
   6. Cohort F: Pancreatic and ampullary
2. Provision of signed and dated informed consent form.
3. Stated willingness to comply with all study procedures and availability for the duration of the study.
4. Age ≥18 years at time of consent.
5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.
6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\]
7. ≤ 5 progressing or new metastatic lesions.
8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.

Exclusion Criteria:

1. Medical comorbidities precluding locally ablative therapies.
2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
3. Progressing intracranial lesions.

Where this trial is running

Sacramento, California

• University of California, Davis — Sacramento, California, United States (RECRUITING)

Study contacts

• Principal investigator: Edward Kim, MD, PhD — University of California, Davis
• Study coordinator: Selina Laqui

Conditions: Esophageal Cancer, Small Bowel Cancer, Gastroesophageal-junction Cancer, Gastric Cancer, Colorectal Cancer, Appendiceal Cancer, Biliary Cancer, Gall Bladder Cancer