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Non-Small-Cell Lung CancerPhase 4NCT06483009

Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy With Cryoablation in NSCLC

A Phase 4 study testing Cryoablation in people with Non-Small-Cell Lung Cancer, run by Shanghai Chest Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
Cryoablation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
Oct 2024to Oct 2027
Phase
Phase 4
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years and ≤75 years.
  • Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic, or recurrent (stage IV) non-squamous NSCLC (as per the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer 9th edition TNM lung cancer staging), with T staging ranging from T1 to T2b, not amenable to surgical treatment and definitive concurrent chemoradiotherapy, and have not previously received systemic treatment.
  • Maximum diameter of the primary lesion <5cm and located in a relatively isolated area, not adjacent to major blood vessels or major structures.
  • Absence of EGFR gene sensitizing mutations and ALK gene fusion mutations confirmed by histopathology specimens.
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), with lesions located within previously irradiated fields considered measurable if confirmed to have progressed.
  • No prior systemic anti-tumor therapy for advanced/metastatic disease. Patients who have previously received platinum-based adjuvant/neoadjuvant chemotherapy, or definitive chemoradiotherapy for advanced disease, may be included if disease progression or recurrence has occurred at least 6 months after the end of the last chemotherapy regimen.
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  • Patients with asymptomatic or stable symptomatic brain metastases may be included if they meet specific conditions: a) Measurable lesions outside the central nervous system. b) Absence of central nervous system symptoms or stable symptoms for at least 2 weeks. c) No need for corticosteroid treatment, or discontinuation of corticosteroid treatment within 7 days before the first dose of study drug, or stable corticosteroid dose reduced to ≤10mg/day prednisone (or equivalent) within 7 days before the first dose of study drug.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival >3 months.
  • Adequate organ function, with the following laboratory criteria:
  • Absolute neutrophil count (ANC) ≥1.5x10^9/L without granulocyte colony-stimulating factor use in the past 14 days.
  • Platelet count ≥100×10^9/L without blood transfusion in the past 14 days.

Who cannot join

  • Pathologically confirmed small cell lung cancer (SCLC), including lung cancer mixed with SCLC and NSCLC.
  • Diagnosed with malignancies other than NSCLC within 5 years before the first dose of study drug (excluding cured basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ carcinoma).
  • Previously received therapy including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting another T cell receptor for stimulation or co-inhibition (e.g., CTLA-4, OX-40, CD137).
  • Active autoimmune diseases requiring systemic treatment within 2 years before the first dose of study drug. Alternative therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment.
  • Pregnant or lactating women
  • Presence of any severe or uncontrollable systemic diseases
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  • Medical history, disease evidence, treatment, or laboratory test abnormalities that may interfere with the study results or hinder subjects' participation in the study throughout its duration, or other conditions deemed unsuitable for enrollment by the investigator due to potential risks.
  • Diffuse lesions in both lungs where ablation therapy cannot improve the condition.
  • Extensive pleural metastases with large amounts of pleural effusion.
  • Difficulty in needle puncture due to proximity of the tumor to major mediastinal vessels or difficulty in selecting a puncture path due to contrast agent allergy or patient non-compliance.
  • Severe impairment of lung function, with maximum ventilation <40%.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Hua Zhong, MD contact

18017321320

eddiedong8@hotmail.com

Zhiqiang Gao, MD contact

About this study

Official title: Efficacy and Safety of Combination Therapy of Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This study aims to investigate the efficacy and safety of immuno-chemotherapy in combination of cryoablation as the first-line treatment of advanced NSCLC

Being tested
Cryoablation
Keywords
cryoablation, immunotherapy, Sintilimab
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.

  • CryoablationDevice

    Cryoablation: For subjects assessed as stable disease (SD) after two cycles of medication, one session is performed under local anesthesia after assessment. The multidisciplinary team, including investigators and radiologists, evaluates the feasibility of tumor ablation based on the size, location, and proximity to major blood vessels. Criteria for eligible lesions include a maximum diameter <5cm, relatively isolated lesion location, and not adjacent to major blood vessels or vital structures. Cryoablation is performed using a 17G IceRod Plus 1.5 cryoablation needle, guided by CT, and avoiding nearby anatomical structures using the Visual-ICE cryoablation system.

Study groups in NCT06483009
Study groupRoleWhat they receive
Combination Therapy of Sintilimab and Chemotherapy with CryoablationExperimentalNot described
Receives: Device: Cryoablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    Assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.

    Measured: up to 3 years

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Proportion of subjects whose tumors were assessed by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.

    Measured: up to 3 years

  2. Disease control rate (DCR)

    Proportion of subjects whose tumors were assessed as CR, PR or stable disease (SD) by the investigators using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST. In case of any discrepancies, the investigators will consult a third party.

    Measured: up to 3 year

  3. Duration of response (DOR)

    The time from onset of response to progression or death due to any reason, whichever occurs earlier

    Measured: up to 3 years

  4. Safety profile

    Number of participants with adverse events as a measure of safety and tolerability.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2027 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483009
Sponsor's protocol ID
IS24069
Status last verified
Aug 2024
First submitted
21 Jun 2024
Last updated
30 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Gao Z, Teng J, Qiao R, Qian J, Pan F, Ma M, Lu J, Zhang B, Chu T, Zhong H. Efficacy and Safety of a Therapy Combining Sintilimab and Chemotherapy With Cryoablation in the First-Line Treatment of Advanced Nonsquamous Non-Small Cell Lung Cancer: Protocol for a Phase II, Pilot, Single-Arm, Single-Center Study. JMIR Res Protoc. 2024 Nov 8;13:e64950. doi: 10.2196/64950.

    PubMed 39514267

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cryoablation in people with Non-Small-Cell Lung Cancer, run by Shanghai Chest Hospital.

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 12 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: 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.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Hua Zhong, MD (18017321320, eddiedong8@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06483009, which also lists 1 linked publication.

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.

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