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Phase II clinical study of argon helium knife combined with immunochemotherapy for advanced or metastatic non-small cell lung cancer

Clinical efficacy and safety of cryoablation combined with immunotherapy in patients with advanced non-small cell lung cancer and primary immune resistance mutation genes

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107868
Enrollment
Unknown
Registered
2025-08-20
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

no small cell lung cancer

Interventions

Test group:Cryoablation combined with Immunochemotherapy
Control group:Immunochemotherapy

Sponsors

Yueyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; 2. Pathological diagnosis of non-small cell lung cancer (adenocarcinoma or squamous cell carcinoma) confirmed by biopsy, EGFR and ALK negative, KRASG12D/KEAT1/STK11 mutation patient; 3. Staging (TNM 8th edition, TxNxM1 stage IV); 4. ECOG physical condition score: 0-1 points, able to tolerate puncture; 5. No anti-tumor treatment has been performed; 6. The main organs function well, without serious hypertension, diabetes and heart disease; 7. Sign the informed consent form; 8. Good compliance, family members agree to cooperate in receiving survival follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal coagulation function and bleeding tendency (must meet the requirement of INR being within the normal range without using anticoagulants within 14 days before randomization); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the premise that the international normalized ratio (INR) of prothrombin time is <=1.5, it is allowed to use low-dose warfarin (1mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes; 2. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 3. Screening for arterial/venous thrombosis events that have occurred within the previous 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (excluding those caused by venous catheterization during previous chemotherapy and judged to have recovered by researchers), and pulmonary embolism; 4. According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
progression-free survival (PFS);

Secondary

MeasureTime frame
Overall survival (OS);objective response rate (ORR);disease control rate (DCR);

Countries

China

Contacts

Public ContactLuo Pan

Yueyang Central Hospital

417006612@qq.com+86 183 9009 8557

Outcome results

None listed

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