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

Sponsor
Zhou Chengzhi
Study ID
NCT06607770
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Sep 1, 2024
Status verified
Oct 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Patients were started on Carrelizumab in combination with Apatinib 2-3 weeks after cryoablation. Karelizumab 200 mg, q3w, and Apatinib 250 mg, qd. Every 3 weeks is a treatment cycle.

Primary Outcome Measure

irAEs rate [ Time Frame: 3 years ]

Central Contacts

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