Freezing tumors and boosting immunity: new hope for lung cancer?
NCT ID NCT06127303
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial is testing whether combining the immunotherapy drug toripalimab with cryoablation (a procedure that freezes and kills tumor cells) can help control advanced non-small cell lung cancer that has started to grow again after initial treatment. The study enrolls 54 adults with stage IV lung cancer who have a limited number of new or growing tumors. The goal is to see if this combination can extend the time before the cancer progresses further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- toripalimab (immunotherapy drug) and cryoablation (freezing tumors)
- What this could lead to
- If it works, this combination could offer a new option to control advanced lung cancer that has started to grow again after first-line immunotherapy.
- What could go wrong
- This is a small, early-phase trial (54 people) with no comparison group, so results may not apply broadly. Cryoablation carries risks like bleeding or infection, and immunotherapy can cause immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 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 to 75 years
- 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: * Voluntary participation and written informed consent; * histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer; * Patients with negative driver genes who develop oligoprogression after receiving standard first-line therapy. The oligoprogression is defined as: 1-5 metastatic lesions, and no more than 3 organs; * Age 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months; * At least one measurable lesion; * Patients were willing to provide adequate blood and tissue samples; * Patients had adequate hematologic, renal, and liver function; * International normalised ratio (INR) ≤1.5 and partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to study treatment; * The woman patients of childbearing age who must agree to take contraceptive methods during the research; * The man patients who must agree to take contraceptive methods during the research and within another 6 months after it. Exclusion Criteria: * cytologically or histologically confirmed combination with small cell lung cancer component or sarcomatoid element; * Previously received targeted therapy for advanced NSCLC (including osimertinib, erlotinib, crizotinib, etc); * Had undergone major surgical operations or had not fully recovered from previous operations within 3 weeks before enrollment; * Known active nervous system (CNS) metastases and/or carcinomatous meningitis; * Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression; * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; patients with stable symptoms after drainage can be enrolled; * History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening; * Clinically uncontrolled active infection, including but not limited to acute pneumonia; * Uncontrollable major epileptic seizure or superior vena cava syndrome; * Previous or current co-occurrence of other malignancies (excluding controllable non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, superficial bladder cancer, or other carcinoma in situ); * Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease; * Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening; * Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle; * Vaccination of live-virus vaccine within 30 days after the start of planned treatment; Inactivated seasonal influenza vaccine was permitted; * Patients has HIV-positive; * Patients judged by the investigator to be inappropriate as a subject of this study. * History of severe allergic, quasi-allergic, or other hypersensitive reactions to chimeric or humanized antibodies or fusion proteins; * Known allergy to biological drugs produced from Chinese hamster ovary cells, or to citrate monohydrate, sodium citrate dihydrate, mannitol, polysorbate (components of the study drug); * Patients who have previously received allogeneic stem cells or parenchymal organ transplants.
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Conditions
The condition(s) this trial relates to.
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
3 sites. 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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Shanghai Chest Hospital
RECRUITINGShanghai, Shanghai Municipality, 200000, China
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Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITINGShanghai, China
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Zhongshan Hospital, Fudan University
NOT_YET_RECRUITINGShanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer