Oligometastatic DiseasePhase 2NCT07333651
125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer
A Phase 2 study testing Standard-of-Care Systemic Therapy and 125I Seed Implantation in people with Oligometastatic Disease, run by Li Min at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oligometastatic Disease
- What is being tested?
- Standard-of-Care Systemic Therapy and 125I Seed Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, 250031
Min Li, M.D., 0531-51665482, liminyingxiang.@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Oligometastatic Disease
- Being tested
- Standard-of-Care Systemic Therapy, 125I Seed Implantation
- Keywords
- lodine-125 Seed Brachytherapy, Oligoprogression, Non-Small Cell Lung Cancer, Colorectal Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard-of-Care Systemic TherapyOther
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 ImplantationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard-of-Care Systemic Therapy; Procedure: 125I Seed Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization up to 12 months
Secondary outcomes (4)
Overall Survival (OS)
Overall survival is defined as the time from randomization to death from any cause.
Measured: From randomization up to 24 months
Time to Initiation of a New Systemic Therapy (TTNT)
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.
Measured: From randomization up to 12 months
Local Control of Treated Lesions
Local control is defined as the absence of in-field progression of oligoprogressive lesions treated with 125I seed implantation, assessed on follow-up imaging.
Measured: From intervention to 12 months after randomization
Safety and Treatment-Related Adverse Events
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).
Measured: From intervention through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study startJan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Min, Jinan Military General Hospital
- Investigators
- Min Li, M.D., Study director, The 960th Hospital of People's Liberation Army (PLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333651
- Sponsor's protocol ID
- 960HP20251214
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07333651
- Acronym / sponsor ID
- 960HP20251214
- Conditions
- Oligometastatic Disease
- Keywords
- lodine-125 Seed Brachytherapy, Oligoprogression, Non-Small Cell Lung Cancer, Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Other: Standard-of-Care Systemic TherapyParticipants 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. |
| 125I Seed Implantation plus Standard of Care | Experimental | Other: Standard-of-Care Systemic Therapy, Procedure: 125I Seed ImplantationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard-of-Care Systemic TherapyStandard systemic anticancer therapy administered according to current clinical guidelines and treating physician discretion, which may include chemotherapy, immunotherapy, targeted therapy, and/or maintenance therapy. | Other | 125I Seed Implantation plus Standard of Care, Standard of Care (SOC) |
| 125I Seed ImplantationImage-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. | Procedure or surgery | 125I Seed Implantation plus Standard of Care |
Primary outcome
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: From randomization up to 24 months
Time to Initiation of a New Systemic Therapy (TTNT)
Time frame: From randomization up to 12 months
Local Control of Treated Lesions
Time frame: From intervention to 12 months after randomization
Safety and Treatment-Related Adverse Events
Time frame: From intervention through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Oligometastatic Disease
Active, not recruitingPhase 2/3
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer
Prostate Cancer, Oligometastasis
RecruitingEarly Phase 1
Real-Time Atherosclerosis Activity After Thoracic Radiotherapy Using Sodium Fluoride Positron Emission Tomography
Oligometastatic Disease
RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Not yet recruitingPhase 2
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
Not yet recruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer
Esophageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min Li, M.D. study director
The 960th Hospital of People's Liberation Army (PLA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard-of-Care Systemic Therapy and 125I Seed Implantation in people with Oligometastatic Disease, run by Li Min at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Li, M.D. (0531-51665482, liminyingxiang.@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From randomization up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.