A Phase 2 interventional study of Iodine-125 (125I) Seed Implantation and cryoablation in Unresectable Solid Tumors, sponsored by Li Min. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Li Min · Phase 2, Interventional, and Treatment
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.
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.
Li Min is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Active, uncontrolled infection, including uncontrolled local infection at the intended procedure site;
Participants receive percutaneous image-guided iodine-125 (125I) seed implantation, followed by image-guided cryoablation within a protocol-defined interval.
Procedure: Sequential 125I Seed Implantation Followed by Cryoablation
Participants receive standardized percutaneous image-guided iodine-125 (125I) seed implantation alone.
Procedure: Iodine-125 (125I) Seed Implantation
Participants receive standardized percutaneous image-guided cryoablation alone.
Procedure: cryoablation
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.
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.
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.
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.
Time frame: 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.
Time frame: From randomization up to 12 months
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.
Time frame: From randomization up to 12 months
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From first procedure up to 12 months
Dosimetry-Outcome Associations
Association between target D90 (unit: Gy; derived from the treatment planning system/DVH) and the incidence of Grade ≥3 treatment-related toxicity (unit: % of participants; assessed per CTCAE v5.0) from baseline through 12 months.
Time frame: From baseline through 12 months
Radiomics Biomarkers
Imaging-derived and radiomics features evaluated for association with local control and/or early response.
Time frame: From baseline through 12 months
Peripheral Blood Biomarker Dynamics
Longitudinal changes in protocol-specified peripheral blood biomarkers and their associations with efficacy/toxicity outcomes.
Time frame: From baseline through 12 months
Plan to share: 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.
Supporting information: Study protocol, Icf
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