Lung CancerPhase 1/2NCT06607770
Safety and Efficacy of Cryoablation With Karelizumab and Apatinib for Multiple Lung Cancers
A Phase 1/2 study testing Karelizumab+Apatinib in people with Lung Cancer, run by Zhou Chengzhi at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Karelizumab+Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and pathological diagnosis of multiple primary lung cancers；
- There were 3 intrapulmonary nodules ≥ the initial diagnosis or preoperative, and there was no lymph node metastasis；
- The maximum lesion diameter ≤ 3 cm；
- 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；
- It is estimated that at least 1 measurable lesion meeting RECIST v1.1 criteria will remain after cryotherapy；
- Male or female≥ 18 years old and ≤ 75 years old；
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- United States Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1；
- Expected survival ≥ 12 weeks；
- 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;
- 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;
- 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.
Who cannot join
- Patients with known EGFR mutations, ALK rearrangements;
- 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;
- 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;
- 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.
- Known or suspected active autoimmune disease (congenital or acquired);
- Known allogeneic organ transplantation (other than corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
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- Hypersensitivity to any component of the monoclonal antibody preparation;
- With interstitial lung disease;
- With other uncontrolled serious medical conditions;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chengzhi Zhou
Guangzhou, Guangdong, 510145
Xiaohong Xie, Master
About this study
Official title: 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
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
- Lung Cancer
- Being tested
- Karelizumab+Apatinib
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karelizumab+ApatinibDrug
Karelizumab 200mg, q3w, and Apatinib 250mg, qd. every 3 weeks as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Drug: Karelizumab+Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
irAEs rate
Incidence of adverse events occurring during treatment
Measured: 3 years
Secondary outcomes (5)
ORR
Proportion of patients whose tumor volume shrinks to a pre-specified value and who can maintain the minimum timeframe requirement, as the sum of the proportion in complete and partial remission
Measured: 3 years
DCR
Number of cases in remission (PR+CR) and stable lesions (SD) after treatment as a percentage of evaluable cases
Measured: 3 years
DOR
the time between the first time a subject in confirmed complete remission (CR) or confirmed partial remission (PR) reaches confirmed complete remission (CR) or confirmed partial remission (PR) and the time of the first disease progression or death of any cause
Measured: 3 years
PFS
Time from start of patient's treatment to disease progression or death from any cause
Measured: 3 years
OS
Time from patient randomization to patient death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Sep 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, doctor, Study director, The First Affiliated Hospital of Guangzhou Medical University,Guangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607770
- Sponsor's protocol ID
- CROC-24-08
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06607770
- Acronym / sponsor ID
- CROC-24-08
- Conditions
- Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Karelizumab+ApatinibPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Clinical and pathological diagnosis of multiple primary lung cancers；
- There were 3 intrapulmonary nodules ≥ the initial diagnosis or preoperative, and there was no lymph node metastasis；
- The maximum lesion diameter ≤ 3 cm；
- 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；
- It is estimated that at least 1 measurable lesion meeting RECIST v1.1 criteria will remain after cryotherapy；
Key exclusion criteria (10 listed)
- Patients with known EGFR mutations, ALK rearrangements;
- 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;
- 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;
- 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.
- Known or suspected active autoimmune disease (congenital or acquired);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karelizumab+ApatinibKarelizumab 200mg, q3w, and Apatinib 250mg, qd. every 3 weeks as a treatment cycle. | Drug | Experimental group |
Primary outcome
irAEs rate
Time frame: 3 years
Incidence of adverse events occurring during treatment
5 secondary outcomes
ORR
Time frame: 3 years
DCR
Time frame: 3 years
DOR
Time frame: 3 years
PFS
Time frame: 3 years
OS
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chengzhi Zhou, doctor study director
The First Affiliated Hospital of Guangzhou Medical University,Guangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Karelizumab+Apatinib in people with Lung Cancer, run by Zhou Chengzhi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengzhi Zhou, doctor (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
irAEs rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.