Status:
RECRUITING
Toripalimab Combined With Cryoablation for First-line Oligo-progression in Driver-negative Advanced NSCLC
Lead Sponsor:
Shanghai Chest Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 chemot...
Eligibility Criteria
Inclusion
- Voluntary participation and written informed consent;
- histologically or cytologically confirmed advanced metastatic (stage IV) non-small cell lung cancer;
- Patients with negative driver genes who develop oligoprogression after receiving standard first-line therapy. The oligoprogression is defined as: 1-5 metastatic lesions, and no more than 3 organs;
- Age 18-75 years old; ECOG PS: 0-1; The expected survival is more than 3 months;
- At least one measurable lesion;
- Patients were willing to provide adequate blood and tissue samples；
- Patients had adequate hematologic, renal, and liver function;
- International normalised ratio (INR) ≤1.5 and partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN within 7 days prior to study treatment;
- The woman patients of childbearing age who must agree to take contraceptive methods during the research;
- The man patients who must agree to take contraceptive methods during the research and within another 6 months after it.
Exclusion
- cytologically or histologically confirmed combination with small cell lung cancer component or sarcomatoid element;
- Previously received targeted therapy for advanced NSCLC (including osimertinib, erlotinib, crizotinib, etc);
- Had undergone major surgical operations or had not fully recovered from previous operations within 3 weeks before enrollment;
- Known active nervous system (CNS) metastases and/or carcinomatous meningitis;
- Spinal cord compression for which operation and/or radical radiotherapy has not been given, or no clinical evidence of stable disease for ≥4 weeks prior to enrollment after treatment for previously diagnosed spinal cord compression;
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; patients with stable symptoms after drainage can be enrolled;
- History of idiopathic pulmonary fibrosis, organized pneumonia (e.g., obliterating bronchiolitis), drug induced pneumonia, idiopathic pneumonia or evidence of active pneumonia during chest CT scanning for screening;
- Clinically uncontrolled active infection, including but not limited to acute pneumonia;
- Uncontrollable major epileptic seizure or superior vena cava syndrome;
- Previous or current co-occurrence of other malignancies (excluding controllable non-melanoma basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the breast or cervix, superficial bladder cancer, or other carcinoma in situ);
- Known hepatic diseases of clinical significance, including active viral hepatitis, alcoholic hepatitis or other hepatitis, liver cirrhosis, fatty liver, hereditary liver disease;
- Active tuberculosis (TB), receiving anti-tuberculosis therapy currently or within one year prior to screening;
- Use of systemic immunosuppressive therapy for any active autoimmune disease within two years prior to Day 1 of the 1st cycle;
- Vaccination of live-virus vaccine within 30 days after the start of planned treatment; Inactivated seasonal influenza vaccine was permitted;
- Patients has HIV-positive;
- Patients judged by the investigator to be inappropriate as a subject of this study.
- History of severe allergic, quasi-allergic, or other hypersensitive reactions to chimeric or humanized antibodies or fusion proteins;
- Known allergy to biological drugs produced from Chinese hamster ovary cells, or to citrate monohydrate, sodium citrate dihydrate, mannitol, polysorbate (components of the study drug);
- Patients who have previously received allogeneic stem cells or parenchymal organ transplants.
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2028
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06127303
Start Date
April 2 2024
End Date
April 2 2028
Last Update
September 5 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200000
2
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
3
Zhongshan Hospital, Fudan University
Shanghai, China