RecruitingPhase 1Phase 2NCT06607770

Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers

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


Sponsor

Zhou Chengzhi

Enrollment

20 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining cryoablation (a procedure that freezes and destroys tumors) with an immunotherapy drug (camrelizumab) and a targeted therapy (apatinib) can help treat people with multiple lung cancers — specifically those who have more than 2 small lung nodules remaining after previous surgery. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with multiple primary lung cancers - You have at least 3 lung nodules at diagnosis or before surgery, with no spread to lymph nodes - The largest nodule is 3 cm or smaller - After previous lung surgery, at least 2 nodules remain, confirmed as minimally invasive or in-situ lesions - You are in good general health (ECOG performance score 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - Your nodules are larger than 3 cm - You have lymph node involvement - You do not meet minimum blood count and organ function requirements Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

DRUGKarelizumab+Apatinib

Karelizumab 200mg, q3w, and Apatinib 250mg, qd. every 3 weeks as a treatment cycle.


Locations(1)

Chengzhi Zhou

Guangzhou, Guangdong, China

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NCT06607770


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