Cryoablation combined with Karelizumab and Apatinib for lung cancer treatment

An Exploratory Study of the Safety and Efficacy of Cryoablation in Combination With Karelizumab and Apatinib for the Treatment of Multiple Primary Lung Cancers Without Known Driver Genes

This study is testing whether using cryoablation together with Karelizumab and Apatinib can safely help people with multiple primary lung cancers that lack known driver genes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangzhou Institute of Respiratory Disease (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, carlizumab, carilizumab, Carelizumab, apatinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06607770 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of cryoablation when used alongside Karelizumab and Apatinib in patients with multiple primary lung cancers that do not have known driver genes. Participants will undergo cryoablation followed by treatment with Karelizumab and Apatinib, with the latter starting 2-3 weeks post-procedure. The study aims to determine the safety profile and effectiveness of this combination therapy in managing lung cancer. Eligible patients will be monitored for treatment response and any adverse effects throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with multiple primary lung cancers and specific pathological criteria.

Not a fit: Patients with lymph node metastasis or those who have undergone multiple surgical resections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients with multiple primary lung cancers.

How similar studies have performed: While there is limited information on similar studies, the combination of cryoablation with targeted therapies is an emerging area of interest in cancer treatment.

Eligibility criteria

Inclusion Criteria:

1. Clinical and pathological diagnosis of multiple primary lung cancers；
2. There were 3 intrapulmonary nodules ≥ the initial diagnosis or preoperative, and there was no lymph node metastasis；
3. The maximum lesion diameter ≤ 3 cm；
4. At most, patients has undergone surgical resection treatment, and there are ≥ 2 remaining intrapulmonary nodules, and the postoperative pathology confirms that it is MIA or AIS；
5. It is estimated that at least 1 measurable lesion meeting RECIST v1.1 criteria will remain after cryotherapy；
6. Male or female≥ 18 years old and ≤ 75 years old；
7. United States Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1；
8. Expected survival ≥ 12 weeks；
9. Vital organ and bone marrow function meets the following requirements:a.Blood routine: absolute neutrophil count (ANC) ≥1.5× 109/L, platelet (PLT) ≥100× 109/L, hemoglobin (HGB) ≥9 g/dL;b.Liver function: serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤2.5 times the ULN, serum albumin (ALB) ≥2.8 g/dL;c.Renal function: serum creatinine (Cr) ≤ 1.5 x ULN, or creatinine clearance ≥ 40 mL/min;
10. Subject with subject sexual partner needs to use one medically approved contraceptive measure (such as intrauterine device, birth control pill or condom, etc.) during study treatment and for 6 months after the end of the study treatment period;
11. Subjects must have signed an IRB/IEC-approved written informed consent form in accordance with competent authority and study site guidelines and be able to comply with protocol-specified visits, treatment protocols, laboratory tests, and related procedures.

Exclusion Criteria:

1. Patients with known EGFR mutations, ALK rearrangements;
2. Conditions that cannot be treated with cryoablation: diffuse lesions in both lungs, extensive pleural metastases with large pleural effusions, tumors adjacent to or encircling large mediastinal vessels, etc;
3. 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;
4. Received the following treatments:a.Received systemic anti-tumor therapy such as chemotherapy, targeted therapy, immunotherapy, etc. within 4 weeks prior to randomization;b.Treatment with any investigational drug within 4 weeks prior to randomization;c.Receipt of high-dose immunosuppressive medications (systemic glucocorticoids greater than 10 mg/day of prednisone or its equivalent) within 4 weeks prior to randomization;d.Major surgery (such as open, thoracotomy, or laparotomy, etc.), or unhealed surgical wounds, ulcers, or fractures within 4 weeks prior to randomization.
5. Known or suspected active autoimmune disease (congenital or acquired);
6. Known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
7. Hypersensitivity to any component of the monoclonal antibody preparation;
8. With interstitial lung disease;
9. With other uncontrolled serious medical conditions;
10. Other acute or chronic illness, psychiatric illness, or abnormal laboratory test values that may result in an increase in the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and the patient is listed as ineligible for this study in the judgment of the investigator.

Where this trial is running

Guangzhou, Guangdong

• Chengzhi Zhou — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chengzhi Zhou, doctor

Conditions Lung Cancer