Actively Recruiting
Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers
Led by Zhou Chengzhi · Updated on 2024-10-15
20
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical and pathological diagnosis of multiple primary lung cancers
- At least 3 lung nodules detected initially or before surgery with no lymph node metastasis
- Maximum lesion diameter 3 cm or less
- At most one prior surgical resection, with at least 2 remaining lung nodules confirmed as minimally invasive adenocarcinoma (MIA) or adenocarcinoma in situ (AIS) by pathology
- At least one measurable lesion remaining after cryoablation according to RECIST v1.1 criteria
- Aged between 18 and 75 years, male or female
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Expected survival of 12 weeks or more
- Adequate vital organ and bone marrow function as defined by specified blood counts and liver and kidney function tests
- Use of medically approved contraception during treatment and for 6 months after treatment
- Signed informed consent and ability to comply with study procedures
You will not qualify if you...
- Presence of EGFR mutations or ALK rearrangements
- Conditions unsuitable for cryoablation such as diffuse lesions in both lungs, extensive pleural metastases with large effusions, or tumors near large mediastinal vessels
- Prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies or other immune checkpoint inhibitors
- Receipt of systemic anti-tumor therapy, investigational drugs, high-dose immunosuppressive medications, or major surgery within 4 weeks prior to randomization
- Known or suspected active autoimmune disease
- History of allogeneic organ or hematopoietic stem cell transplantation (except corneal transplantation)
- Hypersensitivity to monoclonal antibody components
- Presence of interstitial lung disease
- Other uncontrolled serious medical conditions
- Any other acute or chronic illness, psychiatric illness, or abnormal lab results that increase risk or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chengzhi Zhou
Guangzhou, Guangdong, China, 510145
Actively Recruiting
Research Team
C
Chengzhi Zhou, doctor
CONTACT
X
Xiaohong Xie, master
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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