Non-small Cell Lung Cancer (NSCLC)NCT07053215
Efficacy of Argon-Helium Cryoablation Plus PD-1 Inhibitors in NSCLC
A study testing Argon-Helium Cryoablation, Camrelizumab and Platinum-based doublet chemotherapy in people with Non-small Cell Lung Cancer (NSCLC), run by The First Hospital of Hebei Medical University at 1 site in China.
Trial summary
This randomized controlled trial investigated the efficacy and safety of argon-helium cryoablation combined with PD-1 inhibitors compared to PD-1 inhibitors plus chemotherapy for treating non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Argon-Helium Cryoablation, Camrelizumab and Platinum-based doublet chemotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed NSCLC, stage IIIB, IIIC, or IV (AJCC 8th Edition);
- At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Estimated survival time ≥6 months;
- Receiving argon-helium cryoablation combined with PD-1 inhibitor for the first time at our institution (for study group) or standard chemo-immunotherapy (for control group);
- Unable or unwilling to undergo surgical resection for various reasons;
- Karnofsky Performance Status (KPS) score ≥60;
- Conscious and capable of effective communication;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Who cannot join
- Presence of other active malignant tumors;
- Significant uncontrolled hepatic (total bilirubin >1.5 × upper limit of normal [ULN], AST/ALT >2.5 × ULN or >5 × ULN if liver metastases present) or renal dysfunction (creatinine clearance <50 mL/min);
- Non-primary NSCLC (i.e., metastatic from another site);
- Known allergy or contraindication to study drugs or inability to comply with the treatment plan;
- Coexisting active tuberculosis, uncontrolled systemic infections, or other significant pulmonary diseases that would interfere with treatment or outcome assessment;
- Pregnancy or lactation;
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- Severe psychiatric disorders;
- Uncorrected coagulation disorders (e.g., INR >1.5 or platelet count <75 × 109/L);
- Known immunodeficiency syndromes (e.g., HIV infection);
- Symptomatic hemorrhagic pleural effusion requiring urgent intervention;
- Patients who withdrew consent before randomization or were deemed non-compliant by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050031
About this study
Official title: Efficacy of Argon-Helium Cryoablation Combined With PD-1 Inhibitors in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
This randomized controlled trial investigated the efficacy and safety of argon-helium cryoablation combined with PD-1 inhibitors compared to PD-1 inhibitors plus chemotherapy for treating non-small cell lung cancer (NSCLC). The study aimed to evaluate differences in survival, tumor response, immune function, and adverse events.
Read the detailed description
This was a single-center, open-label, randomized controlled trial conducted at the First Hospital of Hebei Medical University, China. Sixty patients with advanced non-small cell lung cancer (NSCLC) were enrolled between December 2020 and December 2023. Patients were randomly assigned (1:1) to either a study group (argon-helium cryoablation combined with PD-1 inhibitor, Camrelizumab) or a control group (PD-1 inhibitor, Camrelizumab, combined with platinum-based doublet chemotherapy). Argon-helium cryoablation was performed prior to PD-1 inhibitor administration in the study group. Both groups received 4 cycles of systemic therapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), changes in immune function markers (CD4+, CD8+, CD4+/CD8+ ratio), and adverse reactions. Patients were followed for up to 1 year. The study aimed to determine if combining cryoablation with PD-1 inhibition offers superior outcomes compared to standard chemo-immunotherapy in NSCLC.
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Being tested
- Argon-Helium Cryoablation, Camrelizumab, Platinum-based doublet chemotherapy
- Keywords
- Argon-helium cryoablation, PD-1 inhibitor, Non-small cell lung cancer, Randomized controlled trial, Efficacy, Immune function
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon-Helium CryoablationDevice
Procedure performed within 7 days before the first dose of PD-1 inhibitor. CT-guided insertion of cryoprobes into the target tumor. Two freeze-thaw cycles: rapid freeze to -135°C to -145°C for 15-20 minutes, followed by thawing.
CamrelizumabDrug
200 mg intravenously every 3 weeks for 4 cycles.
Platinum-based doublet chemotherapyDrug
- Non-squamous NSCLC: Pemetrexed (500 mg/m² IV on day 1) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle.
- Squamous NSCLC: Gemcitabine (1250 mg/m² IV on days 1 and 8) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle.
- Administered for 4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Argon-Helium Cryoablation + PD-1 Inhibitor | Experimental | Patients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles). Receives: Device: Argon-Helium Cryoablation; Drug: Camrelizumab |
| PD-1 Inhibitor + Chemotherapy | Active comparator | Patients received PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks) combined with standard platinum-based doublet chemotherapy for 4 cycles. Receives: Drug: Camrelizumab; Drug: Platinum-based doublet chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Time from randomization to death from any cause.
Measured: From randomization until death, assessed through study completion, an average of 1 year.
Progression-Free Survival (PFS)
Time from randomization to disease progression (RECIST 1.1) or death from any cause, whichever occurred first.
Measured: From randomization until disease progression or death, assessed through study completion, an average of 1 year.
Secondary outcomes (7)
Objective Response Rate (ORR)
Proportion of patients achieving Complete Response (CR) or Partial Response (PR) according to mRECIST criteria.
Measured: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Disease Control Rate (DCR)
Proportion of patients achieving CR, PR, or Stable Disease (SD) according to mRECIST criteria.
Measured: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Change in CD4+ T lymphocyte counts
Change in peripheral blood CD4+ T lymphocyte subset counts from baseline.
Measured: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD8+ T lymphocyte counts
Change in peripheral blood CD8+ T lymphocyte subset counts from baseline.
Measured: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD4+/CD8+ T lymphocyte ratio
Change in the ratio of peripheral blood CD4+ to CD8+ T lymphocytes from baseline.
Measured: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Incidence and severity of Adverse Events (AEs)
Number and grade of AEs according to NCI-CTCAE v5.0.
Measured: From the first dose of study treatment until 30 days after the last dose of study medication (up to approximately 16 weeks).
1-year Progression-Free Survival Rate
Proportion of patients alive and without disease progression at 1 year from randomization.
Measured: At 1 year from randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Dec 2020
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Li, The First Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053215
- Sponsor's protocol ID
- GZ2023116
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Argon-Helium Cryoablation Combined With PD-1 Inhibitors in Non-Small Cell Lung Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07053215
- Acronym / sponsor ID
- GZ2023116
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Keywords
- Argon-helium cryoablation, PD-1 inhibitor, Non-small cell lung cancer, Randomized controlled trial, Efficacy, Immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The First Hospital of Hebei Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial investigated the efficacy and safety of argon-helium cryoablation combined with PD-1 inhibitors compared to PD-1 inhibitors plus chemotherapy for treating non-small cell lung cancer (NSCLC). The study aimed to evaluate differences in survival, tumor response, immune function, and adverse events.
Detailed description
This was a single-center, open-label, randomized controlled trial conducted at the First Hospital of Hebei Medical University, China. Sixty patients with advanced non-small cell lung cancer (NSCLC) were enrolled between December 2020 and December 2023. Patients were randomly assigned (1:1) to either a study group (argon-helium cryoablation combined with PD-1 inhibitor, Camrelizumab) or a control group (PD-1 inhibitor, Camrelizumab, combined with platinum-based doublet chemotherapy). Argon-helium cryoablation was performed prior to PD-1 inhibitor administration in the study group. Both groups received 4 cycles of systemic therapy. The primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), changes in immune function markers (CD4+, CD8+, CD4+/CD8+ ratio), and adverse reactions. Patients were followed for up to 1 year. The study aimed to determine if combining cryoablation with PD-1 inhibition offers superior outcomes compared to standard chemo-immunotherapy in NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Argon-Helium Cryoablation + PD-1 Inhibitor | Experimental | Device: Argon-Helium Cryoablation, Drug: CamrelizumabPatients received argon-helium cryoablation followed by PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks for 4 cycles). |
| PD-1 Inhibitor + Chemotherapy | Active comparator | Drug: Camrelizumab, Drug: Platinum-based doublet chemotherapyPatients received PD-1 inhibitor (Camrelizumab 200 mg IV every 3 weeks) combined with standard platinum-based doublet chemotherapy for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically confirmed NSCLC, stage IIIB, IIIC, or IV (AJCC 8th Edition);
- At least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
- Estimated survival time ≥6 months;
- Receiving argon-helium cryoablation combined with PD-1 inhibitor for the first time at our institution (for study group) or standard chemo-immunotherapy (for control group);
- Unable or unwilling to undergo surgical resection for various reasons;
Key exclusion criteria (11 listed)
- Presence of other active malignant tumors;
- Significant uncontrolled hepatic (total bilirubin >1.5 × upper limit of normal [ULN], AST/ALT >2.5 × ULN or >5 × ULN if liver metastases present) or renal dysfunction (creatinine clearance <50 mL/min);
- Non-primary NSCLC (i.e., metastatic from another site);
- Known allergy or contraindication to study drugs or inability to comply with the treatment plan;
- Coexisting active tuberculosis, uncontrolled systemic infections, or other significant pulmonary diseases that would interfere with treatment or outcome assessment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argon-Helium CryoablationProcedure performed within 7 days before the first dose of PD-1 inhibitor. CT-guided insertion of cryoprobes into the target tumor. Two freeze-thaw cycles: rapid freeze to -135°C to -145°C for 15-20 minutes, followed by thawing. | Device | Argon-Helium Cryoablation + PD-1 Inhibitor |
| Camrelizumab200 mg intravenously every 3 weeks for 4 cycles. | Drug | Argon-Helium Cryoablation + PD-1 Inhibitor, PD-1 Inhibitor + Chemotherapy |
| Platinum-based doublet chemotherapy* Non-squamous NSCLC: Pemetrexed (500 mg/m² IV on day 1) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle. * Squamous NSCLC: Gemcitabine (1250 mg/m² IV on days 1 and 8) plus Carboplatin (AUC 5 mg/mL•min IV on day 1) of each 3-week cycle. * Administered for 4 cycles. | Drug | PD-1 Inhibitor + Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: From randomization until death, assessed through study completion, an average of 1 year.
Time from randomization to death from any cause.
Progression-Free Survival (PFS)
Time frame: From randomization until disease progression or death, assessed through study completion, an average of 1 year.
Time from randomization to disease progression (RECIST 1.1) or death from any cause, whichever occurred first.
7 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Disease Control Rate (DCR)
Time frame: Assessed after 4 cycles of treatment (each cycle is 21 days), at approximately 12 weeks from randomization.
Change in CD4+ T lymphocyte counts
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD8+ T lymphocyte counts
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Change in CD4+/CD8+ T lymphocyte ratio
Time frame: Baseline (Day 1, prior to treatment) and at the end of Cycle 4 (each cycle is 21 days).
Incidence and severity of Adverse Events (AEs)
Time frame: From the first dose of study treatment until 30 days after the last dose of study medication (up to approximately 16 weeks).
1-year Progression-Free Survival Rate
Time frame: At 1 year from randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon-Helium Cryoablation, Camrelizumab and Platinum-based doublet chemotherapy in people with Non-small Cell Lung Cancer (NSCLC), run by The First Hospital of Hebei Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From randomization until death, assessed through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.