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Clinical Trials in China / NCT07450352
Starting soon Phase 2

SEED-CRYO: Sequential 125I Seed Implantation Followed by Cryoablation vs Single-Modality Local Therapy in Unresectable Solid Tumors

NCT07450352 · tracked via the Priya Life Science China tracker
Sponsor
Li Min
Phase
Phase 2
Started
2026-02
Last updated
2026-03-04

Condition(s) studied

Unresectable Solid Tumors

Investigational drug(s) / intervention(s)

Iodine-125 (125I) Seed ImplantationcryoablationSequential 125I Seed Implantation Followed by Cryoablation

Iodine-125 (125I) Seed Implantation: 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.

cryoablation: 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 Cryoablation: 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 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.; * 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.

Primary outcome measure(s)

  • Local Control Rate (LCR) — 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) — 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.

Trial sites (1)

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

More Li Min trials in China

125I Seed Brachytherapy Combined With Immunotherapy for Primary, Recurrent, or Metastatic Malignant Tumors Starting soon
125I Seed Implantation Plus Systemic Therapy for Oligoprogressive NSCLC or Colorectal Cancer Starting soon
Image-Guided 125I Seed Implantation Plus Standard Systemic Therapy for Patients With Multiple Metastatic Lesions Starting soon
PET/CT-Guided Biological Target Volume Delineation and Dose Optimization for Radioactive Seed Implantation Therapy in Malignant Tumors Starting soon
Research on the Optimization of Treatment for Spinal Metastases With Radioactive Particle Implantation Using TPS and Mechanical Dual Simulation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07450352 on ClinicalTrials.gov ↗ ← All trials in China