OncoMatch/Clinical Trials/NCT06607770
Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers
Is NCT06607770 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Karelizumab+Apatinib for lung cancer.
Treatment: Karelizumab+Apatinib — The goal of this clinical trial is to explore the safety and efficacy of cryoablation combined with carlizumab and apatinib in multiple primary lung cancer without known driver genes.Main included population criteria:Clinical and pathological diagnosis of multiple primary lung cancer;Three pulmonary nodules were diagnosed initially or before surgery, without lymph node metastasis;Male or female is 18 years old, and 75 years old;Up to one surgical resection treatment with 2 remaining pulmonary nodules, and postoperative pathology confirmed MIA or AIS and so on.The main questions it aims to answer is safety of cryoablation combined with carilizumab and apatinib in multiple primary lung cancer.Participants will take carplus with apatinib started 2-3 weeks after cryoablation. Carelizumab 200mg, q3w, apatinib 250mg, qd. Every 3 weeks is for one treatment cycle. Until PD, intolerable toxicity, death, patient withdrawal or investigator discretion requires termination.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Excluded: EGFR mutation
Patients with known EGFR mutations [excluded]
Excluded: ALK rearrangement
Patients with known...ALK rearrangements [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior receipt of anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or any other antibody or drug targeting T cell co-stimulation or immune checkpoint pathways
Cannot have received: systemic anti-tumor therapy
Exception: within 4 weeks prior to randomization
Received systemic anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to randomization
Cannot have received: investigational drug
Exception: within 4 weeks prior to randomization
Treatment with any investigational drug within 4 weeks prior to randomization
Cannot have received: high-dose immunosuppressive medications (systemic glucocorticoids greater than 10 mg/day of prednisone or its equivalent)
Exception: within 4 weeks prior to randomization
Receipt of high-dose immunosuppressive medications (systemic glucocorticoids greater than 10 mg/day of prednisone or its equivalent) within 4 weeks prior to randomization
Cannot have received: major surgery (open surgery, thoracotomy, laparotomy)
Exception: within 4 weeks prior to randomization or unhealed surgical wounds, ulcers, or fractures
Major surgery (such as open, thoracotomy, or laparotomy, etc.), or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to randomization
Lab requirements
Blood counts
ANC ≥1.5× 10^9/L, platelet (PLT) ≥100× 10^9/L, hemoglobin (HGB) ≥9 g/dL
Kidney function
serum creatinine ≤ 1.5x ULN, or creatinine clearance ≥ 40 mL/min
Liver function
serum total bilirubin (TBIL) ≤1.5x ULN, ALT and/or AST ≤2.5x ULN, serum albumin (ALB) ≥2.8 g/dL
Vital organ and bone marrow function meets the following requirements: ... see above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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