Non-small Cell Lung CancerNCT06580665
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
A study testing Cryoablation and Serplulimab in people with Non-small Cell Lung Cancer, run by Shanghai Chest Hospital at 5 sites in China.
Trial summary
Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Cryoablation and Serplulimab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 5 sitesChina
- Study dates
- 1 Sep 2024to 11 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested stage Ia, Ib, or IIa (size≤5 cm, T1-T2N0M0), according to the 9th edition of the TNM classification for lung cancer;
- Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
- Age ≥18 years old;
- The ECOG PS score is 0-2;
- Expected survival ≥3 months;
- Patients who are considered high-risk for surgery/radiotherapy or refuse surgery/radiotherapy based on multidisciplinary evaluation;
- Patients who have not received previous immunotherapy with PD-1, PD-L1 or CTLA-4 antibodies;
- All patients must agree to receive cryoablation (with or without Serplulimab) as an initial therapy and sign a study-specific consent form.
Who cannot join
- Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
- Severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/L;
- Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
- The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
- Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
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- Pregnant and lactating women;
- Long-term use of steroid;
- Other circumstances considered inappropriate for participation in this study.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer
Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.
This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Cryoablation, Serplulimab
- Keywords
- Cryoablation, Serplulimab, Early non-small cell lung cancer
- 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.
CryoablationProcedure or surgery
Patients undergo cryoablation.
SerplulimabDrug
Patients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation alone (CA group) | Experimental | Patients undergo cryoablation alone. Receives: Procedure: Cryoablation |
| Cryoablation combined with immunotherapy (I-CA group) | Experimental | Patients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Receives: Procedure: Cryoablation; Drug: Serplulimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival (PFS)
This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment.
Measured: 3 years
Secondary outcomes (4)
1-year, 2-year, and 3-year Objective Response Rate (ORR)
The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment.
Measured: 3 years
Overall Survival (OS)
The time from the start of treatment to the patient's death or the last follow-up, with a maximum observation period of 5 years from randomization.
Measured: 5 years
Incidence of Adverse Events
Adverse events include those related to the cryoablation procedure occurring during or after the procedure, as well as drug-related adverse events caused by immunotherapy.
Measured: 1 year
Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)
This refers to the changes from baseline in the immunological responses following the cryoablation (with or without Serplulimab) and comparison between the two groups, including the percentage and function of lymphocyte phenotypes, the expression of PD-L1, the concentration of IFN-γ levels, etc.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion11 Aug 2030 (estimated)
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 CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Henlius Biotech Co., Ltd., AccuTarget MediPharma (Shanghai) Co., Ltd
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580665
- Sponsor's protocol ID
- IS24040
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06580665
- Acronym / sponsor ID
- IS24040
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Cryoablation, Serplulimab, Early non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Shanghai Henlius Biotech Co., Ltd., AccuTarget MediPharma (Shanghai) Co., Ltd
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 11 Aug 2030 (estimated)
- First posted
- 30 Aug 2024 (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.
Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.
This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation alone (CA group) | Experimental | Procedure: CryoablationPatients undergo cryoablation alone. |
| Cryoablation combined with immunotherapy (I-CA group) | Experimental | Procedure: Cryoablation, Drug: SerplulimabPatients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. |
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 diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested stage Ia, Ib, or IIa (size≤5 cm, T1-T2N0M0), according to the 9th edition of the TNM classification for lung cancer;
- Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
- Age ≥18 years old;
- The ECOG PS score is 0-2;
- Expected survival ≥3 months;
Key exclusion criteria (9 listed)
- Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
- Severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/L;
- Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
- The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
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 |
|---|---|---|
| CryoablationPatients undergo cryoablation. | Procedure or surgery | Cryoablation alone (CA group), Cryoablation combined with immunotherapy (I-CA group) |
| SerplulimabPatients undergo cryoablation. If there are no significant postoperative complications, Serplulimab should be administered immediately. Cycles with Serplulimab repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. | Drug | Cryoablation combined with immunotherapy (I-CA group) |
Primary outcome
3-year progression-free survival (PFS)
Time frame: 3 years
This refers to the length of time between the participant's first onset of disease progression or death from any cause after treatment.
4 secondary outcomes
1-year, 2-year, and 3-year Objective Response Rate (ORR)
Time frame: 3 years
Overall Survival (OS)
Time frame: 5 years
Incidence of Adverse Events
Time frame: 1 year
Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Serplulimab in people with Non-small Cell Lung Cancer, run by Shanghai Chest Hospital at 5 sites 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 9 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: opening soon, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun (+86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (PFS) (time frame: 3 years). 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 30 Aug 2024.