NCT06580665Not yet recruiting
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer
Randomized Clinical Trials Comparing Immunotherapy Plus Cryoablation (I-CA) Versus Cryoablation Alone for Stage I, Selected Stage IIa, Non-Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 30 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 134 (estimated)
- First submitted
- 11 Aug 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Shanghai Chest Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06580665
What you commit to
- Study type: Interventional
- Planned participants: 134
- From 1 Sept 2024 to the primary completion date, 1 Sept 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
- Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
- Long-term use of steroid;
Other illness
- 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.);
Lab values
- Severe liver and kidney function and coagulation function abnormalities, platelet count \<70×109/L;
Other
- Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
- Pregnant and lactating women;
- Other circumstances considered inappropriate for participation in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai Chest Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.