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SEED-CRYO: Sequential 125I Seed Implantation Followed by Cryoablation vs Single-Modality Local Therapy in Unresectable Solid Tumors
Sponsor: Li Min
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-02
Completion Date
2028-07-01
Last Updated
2026-03-04
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, China