125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer

January 2, 2026 updated by: Li Min

Standard-of-Care Systemic Therapy With or Without Image-Guided 125I Seed Implantation in Patients With Oligoprogressive Metastatic Non-Small Cell Lung Cancer or Colorectal Cancer: An Open-Label, Randomized, Controlled Phase 2 Study

Most patients with metastatic cancer eventually develop resistance to systemic therapy. A subset of patients experience oligoprogression, characterized by progression at a limited number of lesions while other disease sites remain controlled by ongoing systemic therapy. This randomized phase 2 trial evaluates whether image-guided 125I seed implantation targeting all oligoprogressive extracranial lesions, combined with standard-of-care systemic therapy, improves progression-free survival compared with standard-of-care systemic therapy alone in patients with metastatic NSCLC or CRC.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, randomized phase 2 controlled trial enrolling adults with histologically confirmed metastatic NSCLC or colorectal cancer who developed extracranial oligoprogression (≤5 progressive lesions) on PET/CT or CT while receiving at least first-line systemic therapy (including maintenance). Eligible patients will be randomized 1:1 to (1) standard-of-care systemic therapy per treating physician discretion, or (2) image-guided 125I seed implantation to all oligoprogressive lesions plus standard-of-care systemic therapy.

Oligoprogression will be determined by predefined imaging response criteria (RECIST and/or PERCIST, depending on baseline imaging modality), with confirmation by designated study radiologists. Follow-up imaging will be performed at 8 weeks (±2 weeks) after randomization and every 12 weeks (±2 weeks) thereafter to assess disease status. The primary endpoint is progression-free survival measured up to 12 months. Secondary endpoints include overall survival, time to initiation of a new systemic therapy, local control of implanted lesions, safety, and quality of life. Optional exploratory objectives may include circulating tumor DNA dynamics and metabolic PET parameters.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250031
        • The 960th Hospital of People's Liberation Army (PLA)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • Histologically or cytologically confirmed metastatic non-small cell lung cancer (NSCLC) or colorectal cancer (CRC).
  • Presence of metastatic disease with extracranial oligoprogression, defined as progression in up to five (≤5) individual lesions on CT or PET/CT imaging, while other known disease sites remain stable or controlled.
  • Received at least one prior line of standard systemic anticancer therapy, including maintenance therapy, for metastatic disease.
  • All oligoprogressive lesions are technically feasible and considered safe for image-guided 125I seed implantation, as determined by the treating interventional team.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Adequate organ function to undergo interventional procedures and systemic therapy, per institutional standards.
  • Ability to understand and willingness to sign written informed consent.

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Leptomeningeal disease or diffuse central nervous system involvement. Uncontrolled infection or serious medical comorbidities that, in the investigator's judgment, would preclude safe participation or interventional procedures.
  • Prior radiotherapy or brachytherapy requiring re-irradiation to the same tumor location planned for 125I seed implantation.
  • Known bleeding diathesis or uncorrectable coagulation disorders contraindicating interventional procedures.
  • Any other condition that, in the investigator's judgment, would make the patient unsuitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care (SOC)
Participants receive standard-of-care systemic anticancer therapy per treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy according to current clinical guidelines and individual molecular profiles.
Other: Standard-of-Care Systemic Therapy
Standard systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy.
Experimental: 125I Seed Implantation plus Standard of Care
Participants undergo image-guided 125I seed implantation to all extracranial oligoprogressive lesions, followed by continuation of standard-of-care systemic anticancer therapy as determined by the treating physician.
Other: Standard-of-Care Systemic Therapy
Standard systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy.
Procedure: 125I Seed Implantation
Image-guided implantation of iodine-125 (125I) radioactive seeds to all extracranial oligoprogressive lesions for local tumor control, performed under CT or PET/CT guidance according to institutional standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: From randomization up to 12 months
Progression-free survival is defined as the time from randomization to systemic disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 and/or PERCIST criteria based on the baseline imaging modality.
From randomization up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: From randomization up to 24 months
Overall survival is defined as the time from randomization to death from any cause.
From randomization up to 24 months
Time to Initiation of a New Systemic Therapy (TTNT)
Time Frame: From randomization up to 12 months
Time to initiation of a new systemic therapy is defined as the time from randomization to the start of a new line or regimen of systemic anticancer therapy due to disease progression or clinical decision.
From randomization up to 12 months
Local Control of Treated Lesions
Time Frame: From intervention to 12 months after randomization
Local control is defined as the absence of in-field progression of oligoprogressive lesions treated with 125I seed implantation, assessed on follow-up imaging.
From intervention to 12 months after randomization
Safety and Treatment-Related Adverse Events
Time Frame: From intervention through 12 months
Safety is assessed by the incidence and severity of adverse events, including procedure-related toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE).
From intervention through 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns of Disease Progression
Time Frame: From the date of randomization until the date of first documented disease progression, assessed up to 24 months.
Patterns of disease progression will be descriptively analyzed, including the development of new metastatic lesions versus progression of pre-existing lesions, based on radiographic and/or clinical assessment at the time of disease progression.
From the date of randomization until the date of first documented disease progression, assessed up to 24 months.
Metabolic Response on PET Imaging
Time Frame: Baseline and first scheduled imaging assessment (approximately 8 weeks after randomization)
Metabolic response on PET imaging is defined as the change from baseline in maximum standardized uptake value (SUVmax) of the target lesion, as measured on PET imaging at baseline and follow-up.
Baseline and first scheduled imaging assessment (approximately 8 weeks after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Min

Investigators

  • Study Director: Min Li, M.D., The 960th Hospital of People's Liberation Army (PLA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

December 16, 2025

First Submitted That Met QC Criteria

January 2, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960HP20251214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request after completion of the study and publication of the primary results. Data to be shared may include demographic information, treatment assignment, key efficacy outcomes, adverse events, and imaging-derived parameters. A data-sharing agreement will be required to ensure appropriate use of the dataset.

IPD Sharing Time Frame

Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication, or until the main study database is closed, whichever occurs first.

IPD Sharing Access Criteria

Qualified researchers affiliated with academic institutions or recognized research organizations may request access to de-identified individual participant data (IPD), including imaging-derived parameters, dosimetric results, and clinical outcome data.

Requests must include a brief research proposal describing the scientific rationale, objectives, and planned analyses. Approval will be granted by the study's principal investigator and institutional ethics committee. Data will be shared through secure institutional data transfer systems after execution of a formal data sharing agreement that ensures patient confidentiality and compliance with applicable privacy regulations.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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