Malignant TumorsPhase 2NCT07277777
125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors
A Phase 2 study testing Immune Checkpoint Inhibitors and 125I Seed Implantation in people with Malignant Tumors, run by Li Min at 1 site in China.
Trial summary
This prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Malignant Tumors
- What is being tested?
- Immune Checkpoint Inhibitors and 125I Seed Implantation
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 80 years.
- Histologically or clinically confirmed primary, recurrent, or metastatic malignant tumor.
- At least one measurable lesion according to RECIST 1.1 or iRECIST.
- Tumor site suitable for 125I seed implantation under CT or PET/CT guidance.
- Planned to receive or eligible to receive an immune checkpoint inhibitor (ICI).
- ECOG performance status 0-2.
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- Adequate organ function:
- ANC ≥ 1.5 × 10⁹/L Platelets ≥ 80 × 10⁹/L Hemoglobin ≥ 90 g/L AST/ALT ≤ 3 × ULN (≤ 5 × ULN for liver metastasis) Creatinine clearance ≥ 50 mL/min
- Life expectancy ≥ 3 months.
- Ability to understand and sign informed consent.
Who cannot join
- Prior I-125 seed implantation at the planned treatment site.
- Active uncontrolled infection or systemic inflammatory disease.
- Known history of autoimmune disease requiring systemic immunosuppression.
- Prior treatment with immune checkpoint inhibitors within the last 4 weeks.
- Uncontrolled coagulopathy or contraindication to interventional seed implantation:
- INR > 1.5 Platelets < 50 × 10⁹/L
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- Tumor location that poses unacceptable procedural risk, including inability to obtain a safe puncture path.
- Severe cardiopulmonary dysfunction (e.g., heart failure, unstable arrhythmia, severe COPD).
- Pregnancy or breastfeeding.
- Known allergy or contraindication to radiopharmaceuticals, contrast agents, or anesthesia agents used during implantation.
- Any condition that, in the investigator's judgment, makes the participant unsuitable for the study (e.g., poor compliance, severe psychiatric disorder).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Min Li, Dr. contact
China1 site
The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, 250031
Min Li, Dr., 0531-51665482, 924787237@qq.com
About this study
Official title: A Prospective, Randomized, Open-Label, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of 125I Seed Interstitial Brachytherapy Combined With Immune Checkpoint Inhibitor Therapy in Patients With Primary, Recurrent, or Metastatic Malignant Tumors Compared With Immune Checkpoint Inhibitor Therapy Alone
This prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Immunotherapy has become an important systemic treatment option, yet many patients experience limited benefit due to low tumor immunogenicity, insufficient T-cell infiltration, and an immunosuppressive tumor microenvironment.
125I seed brachytherapy provides continuous low-dose-rate radiation to the tumor, promoting antigen release, enhancing dendritic cell activation, and potentially converting immunologically "cold" tumors into more responsive "hot" lesions. Integrating localized radiation with systemic immunotherapy may improve tumor response, prolong progression-free survival, and reduce recurrence.
Patients will be randomized 1:1 to receive 125I seed implantation plus immunotherapy or immunotherapy alone. The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), local control, recurrence rate, adverse events, and quality of life. Exploratory analyses will assess radiomics features, subgroup responses, and different patterns of recurrence. This study aims to determine whether adding 125I seed brachytherapy enhances the clinical benefits of immunotherapy across diverse malignant tumors.
Read the detailed description
Patients with malignant tumors-including primary, recurrent, and metastatic disease-often exhibit heterogeneous responses to immune checkpoint inhibitors (ICIs). Limited tumor antigen exposure, poor immune infiltration, and an immunosuppressive tumor microenvironment frequently restrict the efficacy of immunotherapy. Strategies capable of enhancing local tumor immunogenicity and promoting systemic immune activation may improve clinical outcomes.
125I seed interstitial brachytherapy delivers continuous low-dose-rate radiation precisely to the tumor, offering both durable local control and immunomodulatory effects. Low-dose-rate irradiation can induce immunogenic tumor cell death, increase tumor antigen presentation, enhance dendritic cell activation, and promote T-cell recruitment. This process may convert immunologically inactive ("cold") tumors into immunologically active ("hot") lesions, thereby synergizing with ICIs to enhance anti-tumor immunity. Combining these modalities may improve objective response, delay treatment failure, reduce recurrence, and prolong survival.
This prospective, randomized, open-label, parallel-group trial will compare 125I seed brachytherapy plus immunotherapy with immunotherapy alone. Eligible patients will be randomized 1:1. The combination arm will receive CT-guided seed implantation followed by ICI therapy; the control arm will receive ICI monotherapy. All patients will undergo standardized imaging and clinical evaluations at pre-defined intervals.
The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival, disease control rate, duration of response, local control rate, tumor recurrence rate, treatment-related and immune-related adverse events, and patient-reported quality of life. Exploratory analyses will investigate radiomics features associated with response, patterns of recurrence (local, regional, or distant), and subgroup differences across tumor types, disease stages, biomarker profiles, and treatment characteristics. These analyses may help identify imaging or clinical predictors of benefit, refine patient selection, and support biomarker-driven optimization of 125I seed brachytherapy combined with immunotherapy.
- Conditions
- Malignant Tumors
- Being tested
- Immune Checkpoint Inhibitors, 125I Seed Implantation
- Keywords
- lodine-125 Seed Brachytherapy, Immune Checkpoint Inhibitors, Local-Systemic Synergy, Recurrent or Refractory Tumors
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune Checkpoint InhibitorsDrug
Examples include PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) Administered per standard dosing schedule (e.g., every 2-3 weeks)
125I Seed ImplantationOther
PET/CT-guided implantation or CT-guided implantation Dose planning: D90 typically 90-140 Gy (adjusted per tumor type and size) Post-implant dosimetry: D90, V100, V150 recorded
Immune Checkpoint InhibitorsDrug
Same agent class and dosing schedule as the experimental arm Administered until disease progression, unacceptable toxicity, or study completion
| Study group | Role | What they receive |
|---|---|---|
| 125I Seed Brachytherapy + Immunotherapy | Experimental | Participants in this arm will receive CT-guided 125I seed interstitial brachytherapy, followed by systemic immune checkpoint inhibitor (ICI) therapy administered according to the approved dosing schedule for the selected agent. Seed implantation will be planned and delivered using standardized TPS-based dosimetric protocols, and immunotherapy will continue until progression, unacceptable toxicity, or study completion. Receives: Drug: Immune Checkpoint Inhibitors; Other: 125I Seed Implantation |
| Immunotherapy Alone | Active comparator | Participants in this arm will receive systemic immune checkpoint inhibitor (ICI) therapy alone, following the same agent, schedule, and supportive care standards used in the experimental arm. No local radiotherapy or seed implantation will be performed. Treatment will continue until disease progression, unacceptable toxicity, or study completion. Receives: Drug: Immune Checkpoint Inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Proportion of patients achieving complete response (CR) or partial response (PR) as defined by RECIST 1.1 or iRECIST, assessed via CT/MRI/PET-CT.
Measured: Every 6-12 weeks, up to 24 months
Progression-Free Survival (PFS)
Time from randomization to radiographic disease progression or death from any cause.
Measured: Up to 24 months
Secondary outcomes (9)
Failure-Free Survival (FFS)
Time from randomization to the first occurrence of treatment failure, including disease progression, local recurrence, distant metastasis, discontinuation due to adverse events, or death.
Measured: Up to 24 months
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: Up to 36 months
Disease Control Rate (DCR)
Percentage of patients achieving CR, PR, or stable disease (SD), according to RECIST 1.1/iRECIST.
Measured: Every 6-12 weeks, up to 24 months
Duration of Response (DoR)
Time from first documentation of CR/PR until radiographic progression or death.
Measured: Up to 24 months
Local Control Rate (LCR)
Proportion of treated lesions without local progression, based on imaging (CT/MRI/PET-CT) and dosimetric correlation of the implanted region.
Measured: Up to 24 months
Tumor Recurrence Rate
Rate of local or regional tumor recurrence, defined by new lesions or regrowth within the same anatomical region as confirmed by imaging.
Measured: Up to 24 months
Treatment-Related Adverse Events (TRAEs)
Incidence, severity, and type of adverse events associated with treatment, graded according to CTCAE v5.0.
Measured: From baseline until 90 days after last treatment
Immune-Related Adverse Events (irAEs)
Incidence and grade of immunotherapy-related toxicities such as pneumonitis, colitis, dermatitis, endocrinopathies.
Measured: Up to 24 months
Quality of Life (QoL)
Assessed using validated patient-reported instruments (e.g., EORTC QLQ-C30).
Measured: Baseline, Week 12, Week 24, and every 6 months up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- 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 Malignant TumorsStudies 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 two-arm, parallel-group, phase II trial in which eligible patients with recurrent or refractory, unresectable malignant tumors are randomized in a 1:1 ratio to receive either 125I seed interstitial brachytherapy combined with immune checkpoint inhibitor therapy or immune checkpoint inhibitor therapy alone. Treatment allocation remains fixed throughout the study; no crossover between arms is planned. Patients will be treated and followed according to the assigned arm until disease progression, unacceptable toxicity, withdrawal of consent, or study completion.
- 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, Dr., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277777
- Sponsor's protocol ID
- 960HP20251119
- Status last verified
- Jan 2026
- First submitted
- 30 Nov 2025
- Last updated
- 6 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of 125I Seed Interstitial Brachytherapy Combined With Immune Checkpoint Inhibitor Therapy in Patients With Primary, Recurrent, or Metastatic Malignant Tumors Compared With Immune Checkpoint Inhibitor Therapy Alone
- ClinicalTrials.gov ID
- NCT07277777
- Acronym / sponsor ID
- 960HP20251119
- Conditions
- Malignant Tumors
- Keywords
- lodine-125 Seed Brachytherapy, Immune Checkpoint Inhibitors, Local-Systemic Synergy, Recurrent or Refractory Tumors
- 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
- 11 Dec 2025 (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.
This prospective randomized trial evaluates the efficacy and safety of combining 125I seed interstitial brachytherapy with immune checkpoint inhibitor therapy in patients with primary, recurrent, or metastatic malignant tumors. Immunotherapy has become an important systemic treatment option, yet many patients experience limited benefit due to low tumor immunogenicity, insufficient T-cell infiltration, and an immunosuppressive tumor microenvironment.
125I seed brachytherapy provides continuous low-dose-rate radiation to the tumor, promoting antigen release, enhancing dendritic cell activation, and potentially converting immunologically "cold" tumors into more responsive "hot" lesions. Integrating localized radiation with systemic immunotherapy may improve tumor response, prolong progression-free survival, and reduce recurrence.
Patients will be randomized 1:1 to receive 125I seed implantation plus immunotherapy or immunotherapy alone. The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival (OS), disease control rate (DCR), duration of response (DoR), local control, recurrence rate, adverse events, and quality of life. Exploratory analyses will assess radiomics features, subgroup responses, and different patterns of recurrence. This study aims to determine whether adding 125I seed brachytherapy enhances the clinical benefits of immunotherapy across diverse malignant tumors.
Detailed description
Patients with malignant tumors-including primary, recurrent, and metastatic disease-often exhibit heterogeneous responses to immune checkpoint inhibitors (ICIs). Limited tumor antigen exposure, poor immune infiltration, and an immunosuppressive tumor microenvironment frequently restrict the efficacy of immunotherapy. Strategies capable of enhancing local tumor immunogenicity and promoting systemic immune activation may improve clinical outcomes.
125I seed interstitial brachytherapy delivers continuous low-dose-rate radiation precisely to the tumor, offering both durable local control and immunomodulatory effects. Low-dose-rate irradiation can induce immunogenic tumor cell death, increase tumor antigen presentation, enhance dendritic cell activation, and promote T-cell recruitment. This process may convert immunologically inactive ("cold") tumors into immunologically active ("hot") lesions, thereby synergizing with ICIs to enhance anti-tumor immunity. Combining these modalities may improve objective response, delay treatment failure, reduce recurrence, and prolong survival.
This prospective, randomized, open-label, parallel-group trial will compare 125I seed brachytherapy plus immunotherapy with immunotherapy alone. Eligible patients will be randomized 1:1. The combination arm will receive CT-guided seed implantation followed by ICI therapy; the control arm will receive ICI monotherapy. All patients will undergo standardized imaging and clinical evaluations at pre-defined intervals.
The primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include failure-free survival (FFS), overall survival, disease control rate, duration of response, local control rate, tumor recurrence rate, treatment-related and immune-related adverse events, and patient-reported quality of life. Exploratory analyses will investigate radiomics features associated with response, patterns of recurrence (local, regional, or distant), and subgroup differences across tumor types, disease stages, biomarker profiles, and treatment characteristics. These analyses may help identify imaging or clinical predictors of benefit, refine patient selection, and support biomarker-driven optimization of 125I seed brachytherapy combined with immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group, phase II trial in which eligible patients with recurrent or refractory, unresectable malignant tumors are randomized in a 1:1 ratio to receive either 125I seed interstitial brachytherapy combined with immune checkpoint inhibitor therapy or immune checkpoint inhibitor therapy alone. Treatment allocation remains fixed throughout the study; no crossover between arms is planned. Patients will be treated and followed according to the assigned arm until disease progression, unacceptable toxicity, withdrawal of consent, or study completion.
| Arm | Type | Receives |
|---|---|---|
| 125I Seed Brachytherapy + Immunotherapy | Experimental | Drug: Immune Checkpoint Inhibitors, Other: 125I Seed ImplantationParticipants in this arm will receive CT-guided 125I seed interstitial brachytherapy, followed by systemic immune checkpoint inhibitor (ICI) therapy administered according to the approved dosing schedule for the selected agent. Seed implantation will be planned and delivered using standardized TPS-based dosimetric protocols, and immunotherapy will continue until progression, unacceptable toxicity, or study completion. |
| Immunotherapy Alone | Active comparator | Drug: Immune Checkpoint InhibitorsParticipants in this arm will receive systemic immune checkpoint inhibitor (ICI) therapy alone, following the same agent, schedule, and supportive care standards used in the experimental arm. No local radiotherapy or seed implantation will be performed. Treatment will continue until disease progression, unacceptable toxicity, or study completion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 to 80 years.
- Histologically or clinically confirmed primary, recurrent, or metastatic malignant tumor.
- At least one measurable lesion according to RECIST 1.1 or iRECIST.
- Tumor site suitable for 125I seed implantation under CT or PET/CT guidance.
- Planned to receive or eligible to receive an immune checkpoint inhibitor (ICI).
Key exclusion criteria (11 listed)
- Prior I-125 seed implantation at the planned treatment site.
- Active uncontrolled infection or systemic inflammatory disease.
- Known history of autoimmune disease requiring systemic immunosuppression.
- Prior treatment with immune checkpoint inhibitors within the last 4 weeks.
- Uncontrolled coagulopathy or contraindication to interventional seed implantation:
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 |
|---|---|---|
| Immune Checkpoint InhibitorsExamples include PD-1/PD-L1 inhibitors (e.g., pembrolizumab, nivolumab, camrelizumab, sintilimab) Administered per standard dosing schedule (e.g., every 2-3 weeks) | Drug | 125I Seed Brachytherapy + Immunotherapy |
| 125I Seed ImplantationPET/CT-guided implantation or CT-guided implantation Dose planning: D90 typically 90-140 Gy (adjusted per tumor type and size) Post-implant dosimetry: D90, V100, V150 recorded | Other | 125I Seed Brachytherapy + Immunotherapy |
| Immune Checkpoint InhibitorsSame agent class and dosing schedule as the experimental arm Administered until disease progression, unacceptable toxicity, or study completion | Drug | Immunotherapy Alone |
Primary outcome
Objective Response Rate (ORR)
Time frame: Every 6-12 weeks, up to 24 months
Proportion of patients achieving complete response (CR) or partial response (PR) as defined by RECIST 1.1 or iRECIST, assessed via CT/MRI/PET-CT.
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Time from randomization to radiographic disease progression or death from any cause.
9 secondary outcomes
Failure-Free Survival (FFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Time frame: Every 6-12 weeks, up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Local Control Rate (LCR)
Time frame: Up to 24 months
Tumor Recurrence Rate
Time frame: Up to 24 months
Treatment-Related Adverse Events (TRAEs)
Time frame: From baseline until 90 days after last treatment
Immune-Related Adverse Events (irAEs)
Time frame: Up to 24 months
Quality of Life (QoL)
Time frame: Baseline, Week 12, Week 24, and every 6 months up to 24 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 6 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.
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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, Dr. contact
Min Li, Dr. study director
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 Immune Checkpoint Inhibitors and 125I Seed Implantation in people with Malignant Tumors, 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 10 inclusion and 11 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 6 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, Dr. (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?
Objective Response Rate (ORR) (time frame: Every 6-12 weeks, up to 24 months). The study lists 2 primary outcomes in all. 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 6 Jan 2026.