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

NCT07333651 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 960HP20251214
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oligometastatic Disease

Keywords

lodine-125 Seed Brachytherapy; Oligoprogression; Non-Small Cell Lung Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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 Outcomes (4)

• Overall Survival (OS)

  From randomization up to 24 months

• Time to Initiation of a New Systemic Therapy (TTNT)

  From randomization up to 12 months

• Local Control of Treated Lesions

  From intervention to 12 months after randomization

• Safety and Treatment-Related Adverse Events

  From intervention through 12 months

Other Outcomes (2)

• Metabolic Response on PET Imaging

  Baseline and first scheduled imaging assessment (approximately 8 weeks after randomization)

• Patterns of Disease Progression

  From the date of randomization until the date of first documented disease progression, assessed up to 24 months.

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

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

125I Seed Implantation plus Standard of Care

EXPERIMENTAL

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; Procedure: 125I Seed Implantation

Interventions

Standard-of-Care Systemic Therapy OTHER

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.

125I Seed Implantation plus Standard of Care; Standard of Care (SOC)

125I Seed Implantation PROCEDURE

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.

125I Seed Implantation plus Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Min: lead

Study Sites (1)

The 960th Hospital of People's Liberation Army (PLA)

Jinan, Shandong, 250031, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Min Li, M.D.

  The 960th Hospital of People's Liberation Army (PLA)

  STUDY DIRECTOR

Central Study Contacts

Min Li, M.D.

CONTACT

0531-51665482; liminyingxiang.@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Director

Model Details: This is a randomized, parallel-assignment, open-label interventional study comparing standard-of-care systemic therapy alone with image-guided 125I seed implantation plus standard-of-care systemic therapy in patients with oligoprogressive metastatic non-small cell lung cancer or colorectal cancer.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

CN (1)