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NCT Number: NCT06580665

Cryoablation with or Without Serplulimab in Treating Patients with Stage I-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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.);
  • Pregnant and lactating women;
  • Long-term use of steroid;
  • Other circumstances considered inappropriate for participation in this study.

Treatment and study plan

Cryoablation

Procedure

Patients undergo cryoablation.

Serplulimab

Drug

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 1-year, 2-year, and 3-year Objective Response Rate (ORR)

    Time frame: 3 years

    The percentage of patients that achieve complete response (CR) and partial response (PR) after treatment.

  2. Overall Survival (OS)

    Time frame: 5 years

    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.

  3. Incidence of Adverse Events

    Time frame: 1 year

    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.

  4. Potential Predictive and Immunological Biomarkers (lymphocyte phenotypes, PD-L1 expression, cytokines)

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiayuan Sun

CONTACT

[email protected]

+86-021-22200000 ext. 1511

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Collaborators

  • AccuTarget MediPharma (Shanghai) Co., Ltd
  • Shanghai Henlius Biotech Co., Ltd.

Registry information

Official study title

Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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