Small Bowel CancerLIVELONGNCT06101277
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)
A study testing Ablative local therapy in people with Small Bowel Cancer and Colorectal Cancer, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Cancer, Colorectal Cancer, Appendiceal Cancer
- What is being tested?
- Ablative local therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 15 Sep 2039
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have one of the following histologically and/or biochemically confirmed cancers:
- Cohort A: (Cohort removed in protocol version 4.0)
- Cohort B: Small bowel
- Cohort C: Pancreatic and ampullary, colorectal, and appendiceal
- Cohort D: (Cohort removed in protocol version 4.0)
- Provision of signed and dated informed consent form.
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- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years at time of consent.
- 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.
- ≥ 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]
- ≤ 5 progressing or new metastatic lesions.
- All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist.
Who cannot join
- Medical comorbidities precluding locally ablative therapies.
- History of treatment related toxicities that limit or prohibit application of locally ablative therapies.
- Progressing intracranial lesions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
Office of Clinical Research, 916-382-6970, OCRReferral@health.ucdavis.edu
Edward Kim, MD, PhD
About this study
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.
Read the 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
- Small Bowel Cancer, Colorectal Cancer, Appendiceal Cancer, Biliary Cancer, Gall Bladder Cancer, Intrahepatic Cholangiocarcinoma
- Being tested
- Ablative local therapy
- Medical subject headings
- Colorectal Neoplasms, Appendiceal Neoplasms, Biliary Tract Neoplasms, Gallbladder Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablative local therapyDevice
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
| Study group | Role | What they receive |
|---|---|---|
| Ablative local therapy | Experimental | Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy Receives: Device: Ablative local therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with controlled disease
Number of participants with controlled disease 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
Measured: 3 months from the first day of ablative local therapy
Secondary outcomes (3)
Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy
Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy occurring up to 2 years from the first day of ablative local therapy
Measured: Up to 2 years from the first day of ablative local therapy
Median overall survival
Median overall survival stratified by primary tumor type
Measured: Up to 5 years from the first day of ablative local therapy
Time to treatment failure
Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy
Measured: Up to 1 year from the first day of ablative local therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start5 Oct 2023
- Primary completion5 Dec 2033 (estimated)
- Study completion15 Sep 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Edward Kim, MD, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101277
- Sponsor's protocol ID
- UCDCC308
- Other IDs
- P30CA093373
- Acronym
- LIVELONG
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes