NCT07450352

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
25mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Feb 2026Jul 2028

Study Start

First participant enrolled

February 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 4, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.4 years

First QC Date

February 22, 2026

Last Update Submit

February 27, 2026

Conditions

Unresectable Solid Tumors

Keywords

Unresectable solid tumorsIodine-125 seed implantationCryoablationSequential local therapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    From randomization up to 12 months

Secondary Outcomes (6)

  • Local Progression-Free Survival (LPFS)

    From randomization up to 12 months

  • Overall Survival (OS)

    From randomization up to 24 months

  • Early Pain Response

    Baseline to 1 month post-procedure

  • Technical Success

    During the procedure period (day of procedure)

  • Target-Lesion Re-intervention Rate

    From randomization up to 12 months

  • +1 more secondary outcomes

Other Outcomes (3)

  • Dosimetry-Outcome Associations

    From baseline through 12 months

  • Radiomics Biomarkers

    From baseline through 12 months

  • Peripheral Blood Biomarker Dynamics

    From baseline through 12 months

Study Arms (3)

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.

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.

Procedure: Iodine-125 (125I) Seed Implantation

Cryoablation Alone

ACTIVE COMPARATOR

Participants receive standardized percutaneous image-guided cryoablation alone.

Procedure: cryoablation

Interventions

Iodine-125 (125I) Seed ImplantationPROCEDURE

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.

125I Seed Implantation Alone
cryoablationPROCEDURE

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.

Cryoablation Alone
Sequential 125I Seed Implantation Followed by CryoablationPROCEDURE

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.

Sequential 125I Seed Implantation Followed by Cryoablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jinan, Shandong, 250031, China

Location

MeSH Terms

Interventions

Iodine-125Cryosurgery

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Min Li

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

    STUDY DIRECTOR

Central Study Contacts

Min Li, Dr.

CONTACT

0531-51665482liminyingxiang.@163.com

Min Li, Dr.

CONTACT

924787237@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the procedural nature of 125I seed implantation and cryoablation, blinding of participants and treating clinicians is not feasible; therefore, the study is open label. However, imaging evaluators-including independent radiologists and nuclear medicine physicians responsible for tumor response assessment and imaging-based efficacy evaluations-will remain blinded to treatment allocation, with adjudication when necessary to minimize assessment bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Director

Study Record Dates

First Submitted

February 22, 2026

First Posted

March 4, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

March 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Individual participant data (IPD) will be available beginning 6 months after publication of the primary study results and will remain available for 5 years following publication, or until the main study database is closed, whichever occurs first.

Locations

CN(1)