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

NCT ID: NCT06101277

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-05
• Study Completion Date: 2031-01-05

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.

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ablative local therapy

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

Group Type: EXPERIMENTAL

Ablative local therapy

Intervention Type: DEVICE

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

Interventions

Ablative local therapy

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Edward Kim

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis

Sacramento, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Selina Laqui

Role: CONTACT

sblaqui@ucdavis.edu

916-734-0565

Facility Contacts

Selina Laqui, MD, PhD

Role: primary

sblaqui@ucdavis.edu

916-734-0565

Other Identifiers

UCDCC308

Identifier Type: -

Identifier Source: org_study_id