Double attack on tumors: freeze then irradiate shows promise in early trial
NCT ID NCT07450352
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new approach for people with solid tumors that cannot be surgically removed. It combines two treatments: freezing the tumor (cryoablation) and placing tiny radioactive seeds inside it (iodine-125). The goal is to see if doing both steps works better than either treatment alone at controlling the tumor. About 150 adults with various cancers will take part, and the study will measure how long the tumor stays under control and any side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The 960th Hospital of People's Liberation Army (PLA)
Jinan, Shandong, 250031, China
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