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

NCT06101277 | Recruiting DMC FDA Device

• 1 other identifier: UCDCC308
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Esophageal Cancer; Small Bowel Cancer; Gastroesophageal-junction Cancer; Gastric Cancer; Colorectal Cancer; Appendiceal Cancer; Biliary Cancer; Gall Bladder Cancer; Intrahepatic Cholangiocarcinoma; Extrahepatic Cholangiocarcinoma; Oligoprogressive

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Up to 2 years from the first day of ablative local therapy

• Median overall survival

  Up to 5 years from the first day of ablative local therapy

• Time to treatment failure

  Up to 1 year from the first day of ablative local therapy

Study Arms (1)

Ablative local therapy

EXPERIMENTAL

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Device: Ablative local therapy

Interventions

Ablative local therapy DEVICE

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Ablative local therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have one of the following histologically and/or biochemically confirmed cancers:
• Cohort A: Esophageal, Gastroesophageal Junction, Gastric
• Cohort B: Small bowel
• Cohort C: Colorectal and appendiceal
• Cohort D: Biliary including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma
• Cohort E: Hepatocellular carcinoma
• Cohort F: Pancreatic and ampullary
• Provision of signed and dated informed consent form.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Appendiceal Neoplasms; Biliary Tract Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cecal Neoplasms; Cecal Diseases; Biliary Tract Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Edward Kim, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina Laqui

CONTACT

916-734-0565; sblaqui@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 26, 2023
• Study Start: October 5, 2023
• Primary Completion: December 5, 2025
• Study Completion (Estimated): January 5, 2031
• Last Updated: January 6, 2025

Record last verified: 2025-01

Locations

US (1)