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Freezing tumors and boosting immunity: new hope for lung cancer?

NCT ID NCT06127303

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200000, China

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, China

  • Zhongshan Hospital, Fudan University

    NOT_YET_RECRUITING

    Shanghai, China

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