Unresectable Solid TumorsPhase 2NCT07450352
SEED-CRYO: Sequential 125I Seed Implantation Followed by Cryoablation vs Single-Modality Local Therapy in Unresectable Solid Tumors
A Phase 2 study testing Iodine-125 (125I) Seed Implantation, cryoablation and Sequential 125I Seed Implantation Followed by Cryoablation in people with Unresectable Solid Tumors, run by Li Min at 1 site in China.
Trial summary
This open-label, randomized Phase II trial evaluates whether sequential iodine-125 seed implantation followed by cryoablation improves local tumor control versus single-modality local therapy (125I seeds alone or cryoablation alone) in unresectable solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Solid Tumors
- What is being tested?
- Iodine-125 (125I) Seed Implantation, cryoablation and Sequential 125I Seed Implantation Followed by Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to 1 Jul 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
- Adults aged ≥18 years;
- Histologically or cytologically confirmed solid tumor that is unresectable and for which local therapy is clinically appropriate;
- At least one prespecified target lesion suitable for percutaneous image-guided treatment and considered technically feasible for both 125I seed implantation and cryoablation per investigator assessment (and protocol-defined anatomic/dosimetric safety criteria);
- ECOG performance status 0-2;
- Adequate organ function, acceptable coagulation status, and the ability to safely undergo percutaneous image-guided procedures;
- Written informed consent provided.
Who cannot join
- Prior 125I seed implantation or cryoablation to the same target lesion(s), or other local therapy to the target lesion(s);
- Target lesion location or anatomy that, in the investigator's judgment, makes either procedure unsafe or unlikely to achieve protocol-defined coverage/ablation (e.g., inability to meet organ-at-risk constraints or required safety margins);
- Uncontrolled bleeding risk or coagulopathy not correctable per protocol; inability to safely hold/bridge anticoagulants/antiplatelets as required.
- Active, uncontrolled infection, including uncontrolled local infection at the intended procedure site;
- Clinically significant uncontrolled comorbidities that increase procedural risk;
- Severe organ dysfunction that precludes procedures or follow-up, per protocol-defined thresholds.;
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- Pregnancy or breastfeeding;
- Known hypersensitivity to materials/medications essential for the procedures (e.g., contrast agents or anesthetics) that cannot be adequately managed;
- Any condition that would impair reliable outcome assessment or adherence (e.g., inability to undergo required imaging, expected poor compliance), per investigator judgment.
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, liminyingxiang.@163.com
About this study
Official title: A Randomized Phase II Study of Sequential Iodine-125 Seed Implantation Followed by Cryoablation Versus Iodine-125 Seed Implantation Alone or Cryoablation Alone in Unresectable Solid Tumors
This open-label, randomized Phase II trial evaluates whether sequential iodine-125 seed implantation followed by cryoablation improves local tumor control versus single-modality local therapy (125I seeds alone or cryoablation alone) in unresectable solid tumors.
The study is based on a complementary treatment rationale: cryoablation provides rapid cytoreduction of the dominant tumor component, while 125I seed brachytherapy delivers sustained low-dose-rate irradiation that may better suppress residual viable tumor at the periphery and microscopic extension zones. The trial is designed to determine whether this spatial and temporal complementarity translates into superior local disease control without unacceptable toxicity.
Read more
Participants will be randomized in parallel to one of three arms: (1) sequential 125I seed implantation followed by cryoablation within a protocol-defined interval, (2) 125I seed implantation alone, or (3) cryoablation alone. Treatment assignment is open label; imaging-based efficacy endpoints will be assessed using a standard blinded assessment process (blinded evaluators), according to protocol-defined criteria.
The primary endpoint is local control rate (LCR) of prespecified target lesions and progression-free survival (PFS). Key secondary endpoints are local progression-free survival (LPFS), overall survival (OS), early pain response, technical success, target-lesion re-intervention rate, and safety (including grade ≥3 treatment-emergent adverse events, CTCAE v5.0). Exploratory analyses include dosimetry-outcome associations, imaging/radiomics biomarkers, and peripheral blood biomarker dynamics.
Read the detailed description
This open-label, randomized Phase II trial aims to evaluate, in patients with unresectable solid tumors, whether a sequential local treatment strategy-percutaneous image-guided iodine-125 (125I) seed implantation followed by cryoablation within a protocol-specified time window-can achieve superior tumor local control compared with single-modality local therapy (125I seed implantation alone or cryoablation alone), while maintaining acceptable safety, thereby providing methodological support and effect-size estimates for subsequent Phase III confirmatory studies.
The study is based on the "spatial-temporal complementarity" of two local modalities. Cryoablation can rapidly induce cytotoxic tumor destruction and reduce tumor burden; however, residual viable cells may persist in the peripheral infiltrative zone, sub-millimeter microscopic remnants, and low-temperature gradient regions near the ablation margin. 125I seed brachytherapy delivers continuous low-dose-rate irradiation and may provide sustained suppression of marginal residual disease and microscopic extension. The trial hypothesis is that, under standardized image guidance and treatment planning/quality control, combining the rapid debulking effect of cryoablation with the sustained inhibitory effect of ^125I seeds will reduce the risk of local recurrence/progression, prolong local disease control, and improve overall local efficacy without a disproportionate increase in severe toxicity.
Eligible participants who complete baseline assessments will be randomized in parallel at a 1:1:1 ratio to one of three treatment arms: (1) sequential combination arm-125I seed implantation followed by cryoablation within a protocol-defined interval; (2) 125I seed implantation alone arm-standardized 125I seed implantation only; or (3) cryoablation alone arm-standardized cryoablation only. Owing to the nature of the interventions, treatment allocation is open label. To minimize assessment bias, all imaging-based efficacy endpoints will be evaluated using a prespecified blinded assessment process by independent assessors who are not involved in treatment delivery and are blinded to treatment assignment; adjudication will be performed when necessary to ensure objective and consistent endpoint determination.
All participants will undergo baseline evaluations before treatment, including tumor burden assessment and confirmation of target lesions, prior treatment history, physical examination and laboratory tests, pain and quality-of-life instruments, and imaging-based staging and target-lesion measurements. Target lesions will be prespecified at baseline as the subjects of subsequent local endpoint assessments. 125I seed implantation will be performed under CT or other site-qualified imaging guidance, with standardized documentation of key planning and dosimetric parameters, including prescription dose, target coverage, and organ-at-risk constraints. Cryoablation will likewise be performed under image guidance according to uniform technical specifications, and technical success and peri-procedural events will be recorded in a standardized manner. In the sequential combination arm, the interval between the two procedures will be explicitly defined in the protocol to ensure comparability of the treatment window across centers.
Endpoints are focused on local control, disease progression, and safety. The primary endpoints are the local control rate (LCR) of prespecified target lesions and progression-free survival (PFS). Key secondary endpoints include local progression-free survival (LPFS), overall survival (OS), early pain response, technical success, target-lesion re-intervention rate, and safety (with particular attention to grade ≥3 treatment-emergent adverse events graded and attributed per CTCAE v5.0). Exploratory analyses include associations between dosimetric parameters and efficacy/toxicity outcomes, imaging/radiomics biomarkers, and the dynamics of peripheral blood biomarkers, to inform protocol refinement and future patient stratification.
- Conditions
- Unresectable Solid Tumors
- Being tested
- Iodine-125 (125I) Seed Implantation, cryoablation, Sequential 125I Seed Implantation Followed by Cryoablation
- Keywords
- Unresectable solid tumors, Iodine-125 seed implantation, Cryoablation, Sequential local therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iodine-125 (125I) Seed ImplantationProcedure or surgery
Percutaneous, image-guided implantation of 125I radioactive seeds into the prespecified target lesion(s) according to a protocol-defined treatment plan. Key planning and dosimetric parameters (e.g., prescription dose, target coverage, and organ-at-risk constraints) are recorded per protocol.
cryoablationProcedure or surgery
Percutaneous, image-guided cryoablation of the prespecified target lesion(s) performed using a standardized protocol-defined technique (e.g., applicator placement and freeze-thaw cycles) with documentation of technical success and peri-procedural events per protocol.
Sequential 125I Seed Implantation Followed by CryoablationProcedure or surgery
Combined sequential local therapy consisting of 125I seed implantation followed by cryoablation within a protocol-defined interval; both procedures are performed under image guidance and documented according to protocol-specified standards.
| Study group | Role | What they receive |
|---|---|---|
| Sequential 125I Seed Implantation Followed by Cryoablation | Experimental | Participants receive percutaneous image-guided iodine-125 (125I) seed implantation, followed by image-guided cryoablation within a protocol-defined interval. Receives: Procedure: Sequential 125I Seed Implantation Followed by Cryoablation |
| 125I Seed Implantation Alone | Active comparator | Participants receive standardized percutaneous image-guided iodine-125 (125I) seed implantation alone. Receives: Procedure: Iodine-125 (125I) Seed Implantation |
| Cryoablation Alone | Active comparator | Participants receive standardized percutaneous image-guided cryoablation alone. Receives: Procedure: cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate (LCR)
Proportion of prespecified target lesion(s) without local progression/recurrence as determined by protocol-defined imaging criteria. Imaging-based assessments are performed by blinded independent reviewers with adjudication as needed.
Measured: From randomization up to 12 months
Progression-Free Survival (PFS)
Time from randomization to first documentation of disease progression (per protocol-defined criteria) or death from any cause, whichever occurs first.
Measured: From randomization up to 12 months
Secondary outcomes (6)
Local Progression-Free Survival (LPFS)
Time from randomization to local progression of the prespecified target lesion(s) or death from any cause, whichever occurs first.
Measured: From randomization up to 12 months
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization up to 24 months
Early Pain Response
Pain intensity from baseline to 1 month postoperatively will be assessed using the Visual Analogue Scale (VAS; 0-10 points, where 0 indicates no pain and 10 indicates the worst pain imaginable; higher scores indicate more severe pain) and will be expressed as the absolute change (ΔVAS = VAS_[1 month postoperatively] - VAS_[baseline], unit: points; ΔVAS < 0 indicates pain relief).
Measured: Baseline to 1 month post-procedure
Technical Success
Successful completion of the assigned procedure(s) per protocol-defined technical criteria (e.g., planned seed implantation achieved; cryoablation delivered as planned).
Measured: During the procedure period (day of procedure)
Target-Lesion Re-intervention Rate
Proportion of participants requiring any additional local intervention for the prespecified target lesion(s) after initial assigned treatment.
Measured: From randomization up to 12 months
Safety (Grade ≥3 Treatment-Emergent Adverse Events)
Incidence of grade ≥3 treatment-emergent adverse events (TEAEs) graded per CTCAE v5.0; includes serious adverse events and procedure-related complications per protocol.
Measured: From first procedure up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study startFeb 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Solid 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 multicenter, open-label, randomized, parallel-group Phase II interventional study with three arms (1:1:1 allocation): (1) 125I seed implantation followed by sequential cryoablation, (2) 125I seed implantation alone, and (3) cryoablation alone. Imaging-based efficacy endpoints are assessed by independent blinded reviewers, with adjudication when needed.
- Masking
- None (open label)
- Enrolment
- 150 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, Study director, The 960th Hospital of People's Liberation Army (PLA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450352
- Sponsor's protocol ID
- 960HP20260210
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 4 Mar 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 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Sequential Iodine-125 Seed Implantation Followed by Cryoablation Versus Iodine-125 Seed Implantation Alone or Cryoablation Alone in Unresectable Solid Tumors
- ClinicalTrials.gov ID
- NCT07450352
- Acronym / sponsor ID
- 960HP20260210
- Conditions
- Unresectable Solid Tumors
- Keywords
- Unresectable solid tumors, Iodine-125 seed implantation, Cryoablation, Sequential local therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 4 Mar 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.
This open-label, randomized Phase II trial evaluates whether sequential iodine-125 seed implantation followed by cryoablation improves local tumor control versus single-modality local therapy (125I seeds alone or cryoablation alone) in unresectable solid tumors.
The study is based on a complementary treatment rationale: cryoablation provides rapid cytoreduction of the dominant tumor component, while 125I seed brachytherapy delivers sustained low-dose-rate irradiation that may better suppress residual viable tumor at the periphery and microscopic extension zones. The trial is designed to determine whether this spatial and temporal complementarity translates into superior local disease control without unacceptable toxicity.
Participants will be randomized in parallel to one of three arms: (1) sequential 125I seed implantation followed by cryoablation within a protocol-defined interval, (2) 125I seed implantation alone, or (3) cryoablation alone. Treatment assignment is open label; imaging-based efficacy endpoints will be assessed using a standard blinded assessment process (blinded evaluators), according to protocol-defined criteria.
The primary endpoint is local control rate (LCR) of prespecified target lesions and progression-free survival (PFS). Key secondary endpoints are local progression-free survival (LPFS), overall survival (OS), early pain response, technical success, target-lesion re-intervention rate, and safety (including grade ≥3 treatment-emergent adverse events, CTCAE v5.0). Exploratory analyses include dosimetry-outcome associations, imaging/radiomics biomarkers, and peripheral blood biomarker dynamics.
Detailed description
This open-label, randomized Phase II trial aims to evaluate, in patients with unresectable solid tumors, whether a sequential local treatment strategy-percutaneous image-guided iodine-125 (125I) seed implantation followed by cryoablation within a protocol-specified time window-can achieve superior tumor local control compared with single-modality local therapy (125I seed implantation alone or cryoablation alone), while maintaining acceptable safety, thereby providing methodological support and effect-size estimates for subsequent Phase III confirmatory studies.
The study is based on the "spatial-temporal complementarity" of two local modalities. Cryoablation can rapidly induce cytotoxic tumor destruction and reduce tumor burden; however, residual viable cells may persist in the peripheral infiltrative zone, sub-millimeter microscopic remnants, and low-temperature gradient regions near the ablation margin. 125I seed brachytherapy delivers continuous low-dose-rate irradiation and may provide sustained suppression of marginal residual disease and microscopic extension. The trial hypothesis is that, under standardized image guidance and treatment planning/quality control, combining the rapid debulking effect of cryoablation with the sustained inhibitory effect of ^125I seeds will reduce the risk of local recurrence/progression, prolong local disease control, and improve overall local efficacy without a disproportionate increase in severe toxicity.
Eligible participants who complete baseline assessments will be randomized in parallel at a 1:1:1 ratio to one of three treatment arms: (1) sequential combination arm-125I seed implantation followed by cryoablation within a protocol-defined interval; (2) 125I seed implantation alone arm-standardized 125I seed implantation only; or (3) cryoablation alone arm-standardized cryoablation only. Owing to the nature of the interventions, treatment allocation is open label. To minimize assessment bias, all imaging-based efficacy endpoints will be evaluated using a prespecified blinded assessment process by independent assessors who are not involved in treatment delivery and are blinded to treatment assignment; adjudication will be performed when necessary to ensure objective and consistent endpoint determination.
All participants will undergo baseline evaluations before treatment, including tumor burden assessment and confirmation of target lesions, prior treatment history, physical examination and laboratory tests, pain and quality-of-life instruments, and imaging-based staging and target-lesion measurements. Target lesions will be prespecified at baseline as the subjects of subsequent local endpoint assessments. 125I seed implantation will be performed under CT or other site-qualified imaging guidance, with standardized documentation of key planning and dosimetric parameters, including prescription dose, target coverage, and organ-at-risk constraints. Cryoablation will likewise be performed under image guidance according to uniform technical specifications, and technical success and peri-procedural events will be recorded in a standardized manner. In the sequential combination arm, the interval between the two procedures will be explicitly defined in the protocol to ensure comparability of the treatment window across centers.
Endpoints are focused on local control, disease progression, and safety. The primary endpoints are the local control rate (LCR) of prespecified target lesions and progression-free survival (PFS). Key secondary endpoints include local progression-free survival (LPFS), overall survival (OS), early pain response, technical success, target-lesion re-intervention rate, and safety (with particular attention to grade ≥3 treatment-emergent adverse events graded and attributed per CTCAE v5.0). Exploratory analyses include associations between dosimetric parameters and efficacy/toxicity outcomes, imaging/radiomics biomarkers, and the dynamics of peripheral blood biomarkers, to inform protocol refinement and future patient stratification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a multicenter, open-label, randomized, parallel-group Phase II interventional study with three arms (1:1:1 allocation): (1) 125I seed implantation followed by sequential cryoablation, (2) 125I seed implantation alone, and (3) cryoablation alone. Imaging-based efficacy endpoints are assessed by independent blinded reviewers, with adjudication when needed.
| Arm | Type | Receives |
|---|---|---|
| Sequential 125I Seed Implantation Followed by Cryoablation | Experimental | Procedure: Sequential 125I Seed Implantation Followed by CryoablationParticipants receive percutaneous image-guided iodine-125 (125I) seed implantation, followed by image-guided cryoablation within a protocol-defined interval. |
| 125I Seed Implantation Alone | Active comparator | Procedure: Iodine-125 (125I) Seed ImplantationParticipants receive standardized percutaneous image-guided iodine-125 (125I) seed implantation alone. |
| Cryoablation Alone | Active comparator | Procedure: cryoablationParticipants receive standardized percutaneous image-guided cryoablation alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged ≥18 years;
- Histologically or cytologically confirmed solid tumor that is unresectable and for which local therapy is clinically appropriate;
- At least one prespecified target lesion suitable for percutaneous image-guided treatment and considered technically feasible for both 125I seed implantation and cryoablation per investigator assessment (and protocol-defined anatomic/dosimetric safety criteria);
- ECOG performance status 0-2;
- Adequate organ function, acceptable coagulation status, and the ability to safely undergo percutaneous image-guided procedures;
Key exclusion criteria (9 listed)
- Prior 125I seed implantation or cryoablation to the same target lesion(s), or other local therapy to the target lesion(s);
- Target lesion location or anatomy that, in the investigator's judgment, makes either procedure unsafe or unlikely to achieve protocol-defined coverage/ablation (e.g., inability to meet organ-at-risk constraints or required safety margins);
- Uncontrolled bleeding risk or coagulopathy not correctable per protocol; inability to safely hold/bridge anticoagulants/antiplatelets as required.
- Active, uncontrolled infection, including uncontrolled local infection at the intended procedure site;
- Clinically significant uncontrolled comorbidities that increase procedural risk;
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 |
|---|---|---|
| Iodine-125 (125I) Seed ImplantationPercutaneous, image-guided implantation of 125I radioactive seeds into the prespecified target lesion(s) according to a protocol-defined treatment plan. Key planning and dosimetric parameters (e.g., prescription dose, target coverage, and organ-at-risk constraints) are recorded per protocol. | Procedure or surgery | 125I Seed Implantation Alone |
| cryoablationPercutaneous, image-guided cryoablation of the prespecified target lesion(s) performed using a standardized protocol-defined technique (e.g., applicator placement and freeze-thaw cycles) with documentation of technical success and peri-procedural events per protocol. | Procedure or surgery | Cryoablation Alone |
| Sequential 125I Seed Implantation Followed by CryoablationCombined sequential local therapy consisting of 125I seed implantation followed by cryoablation within a protocol-defined interval; both procedures are performed under image guidance and documented according to protocol-specified standards. | Procedure or surgery | Sequential 125I Seed Implantation Followed by Cryoablation |
Primary outcome
Local Control Rate (LCR)
Time frame: From randomization up to 12 months
Proportion of prespecified target lesion(s) without local progression/recurrence as determined by protocol-defined imaging criteria. Imaging-based assessments are performed by blinded independent reviewers with adjudication as needed.
Progression-Free Survival (PFS)
Time frame: From randomization up to 12 months
Time from randomization to first documentation of disease progression (per protocol-defined criteria) or death from any cause, whichever occurs first.
6 secondary outcomes
Local Progression-Free Survival (LPFS)
Time frame: From randomization up to 12 months
Overall Survival (OS)
Time frame: From randomization up to 24 months
Early Pain Response
Time frame: Baseline to 1 month post-procedure
Technical Success
Time frame: During the procedure period (day of procedure)
Target-Lesion Re-intervention Rate
Time frame: From randomization up to 12 months
Safety (Grade ≥3 Treatment-Emergent Adverse Events)
Time frame: From first procedure up to 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 4 Mar 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 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 Iodine-125 (125I) Seed Implantation, cryoablation and Sequential 125I Seed Implantation Followed by Cryoablation in people with Unresectable Solid 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 6 inclusion and 9 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 4 Mar 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?
Local Control Rate (LCR) (time frame: From randomization up to 12 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 4 Mar 2026.