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A Prospective, Single-Arm, Dual-Center Study on the Efficacy and Safety of Cryoablation Combined with Neoadjuvant Immunotherapy and Chemotherapy for Resectable Stage II-IIIB Non-Small Cell Lung Cancer

A Prospective, Single-Arm, Dual-Center Study on the Efficacy and Safety of Cryoablation Combined with Neoadjuvant Immunotherapy and Chemotherapy for Resectable Stage II-IIIB Non-Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116611
Enrollment
Unknown
Registered
2026-01-13
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Experimental group:Preoperative cryoablation combined with immunotherapy and chemotherapy treatment

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Age >= 18 years old or = 1%); 5) According to the surgeon's assessment, the total lung function can withstand the proposed lung resection surgery; 6) ECOG PS score 0-1 points; 7) According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), there must be at least one measurable lesion; 8) There has been no targeted anti-tumor treatment in the past; 9) Having good organ function; 10) Women of childbearing age must undergo a serum pregnancy test within 3 days before their first medication, and the result must be negative; 11) The subjects are willing and able to comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study; 12) Can understand and be willing to sign a written informed consent document approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1) The compound confirmed by pathology contains components of small cell lung cancer; 2) Due to anatomical reasons of tumors, it is difficult to undergo cryotherapy; 3) Severe coagulation dysfunction or the use of anticoagulants, antiplatelet agents, anti angiogenic drugs, etc., which cannot be stopped in the short term; 4) Previously received chest radiation therapy or immunotherapy; 5) Active autoimmune diseases that require systemic treatment within 2 years prior to enrollment; Alternative therapies (such as thyroid hormones, insulin, or physiological corticosteroids for the treatment of adrenal or pituitary dysfunction) are not considered systemic treatments; 6) Insufficient lung function to tolerate surgery; 7) Known history of HIV infection (i.e. HIV 1/2 antibody positive); 8) Untreated active hepatitis B or active hepatitis C virus infection; 9) Pregnant or lactating women; 10) Any serious or uncontrollable systemic illness, including mental illness;

Design outcomes

Primary

MeasureTime frame
TNM staging reduction rate;Complete pathological remission rate;

Secondary

MeasureTime frame
Main pathological remission rate;Disease-free survival period;Objective response rate;R0 resection rate;

Countries

China

Contacts

Public ContactHaitao Huang, Cheng Ji

The First Affiliated Hospital of Soochow University

jicheng_suda@163.com+86 180 2130 7500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026