Actively Recruiting
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
Led by Shanghai Chest Hospital · Updated on 2025-09-05
54
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Immunotherapy with programmed death-1(PD-1) inhibitors is now standard therapy for first-line use in patients with driver-negative advanced NSCLC, whether as single-agent or in combination with chemotherapy. After progression of first-line immunotherapy, NSCLC patients may be treated with chemotherapy, radiotherapy or targeted therapies, among others. Recently, Immune Checkpoint inhibitors (ICIs) rechallenge has become a highly anticipated option. Although the objective response rate of the ICIs rechallenge patients has decreased substantially compared with the efficacy of the first ICI treatment, nearly 50% of patients can regain disease control. Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate viable tumour cells in target tissues. It has been reported that ablation can enhance immune response. The objective of this study was to evaluate the efficacy and safety of toripalimab (PD-1) in combination with cryoablation in the treatment of oligometastatic driver-negative advanced NSCLC after first-line immunotherapy progress.
CONDITIONS
Official Title
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer
- Negative driver genes and developed oligo-progression after standard first-line therapy (1-5 metastatic lesions, no more than 3 organs)
- Age between 18 and 75 years
- ECOG performance status 0-1
- Expected survival longer than 3 months
- At least one measurable lesion
- Willingness to provide adequate blood and tissue samples
- Adequate hematologic, renal, and liver function
- International normalized ratio (INR) ≤1.5 and partial thromboplastin time (PTT or aPTT) ≤1.5 times upper limit of normal within 7 days before study treatment
- Women of childbearing age must agree to use contraception during the study
- Men must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence of small cell lung cancer component or sarcomatoid element
- Previous targeted therapy for advanced NSCLC (e.g., osimertinib, erlotinib, crizotinib)
- Major surgery within 3 weeks before enrollment or not fully recovered from surgery
- Active central nervous system metastases or carcinomatous meningitis
- Unstable spinal cord compression
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (stable after drainage allowed)
- History of pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, or active pneumonia on screening CT
- Clinically uncontrolled active infection including acute pneumonia
- Uncontrollable major epileptic seizure or superior vena cava syndrome
- Other current or previous malignancies except certain controlled skin, breast, cervix, or bladder cancers
- Significant liver diseases including active hepatitis or cirrhosis
- Active tuberculosis or recent anti-tuberculosis therapy
- Use of systemic immunosuppressive therapy for active autoimmune disease within 2 years before treatment
- Live-virus vaccination within 30 days after treatment start (inactivated flu vaccine allowed)
- HIV positive status
- History of severe allergic reactions to chimeric/humanized antibodies or study drug components
- Previous allogeneic stem cell or organ transplant
- Investigator judgment deeming participant inappropriate for study participation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
2
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Not Yet Recruiting
3
Zhongshan Hospital, Fudan University
Shanghai, China
Not Yet Recruiting
Research Team
Z
Ziming Li, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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