Lung CancerPhase 1/2CCA-MPLCNCT04201990
Cryoablation Combined With Camrelizumab and Apatinib for Multiprimary Lung Cancer
A Phase 1/2 study testing Camrelizumab and Apatinib in people with Lung Cancer, run by ShiYue Li.
Trial summary
Objective: This study is to observe the safety and therapeutic effect of cryoablation combined with pd-1 antibody immunotherapy and anti-angiogenesis therapy in multiple primary lung cancer (MPLC) patients. 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?
- Camrelizumab and Apatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 muitiple primary lung cancer.
- more than three pulmonary nodules and without lymph node metastasis.
- the maximum lesion less than three centimeters in diameter.
- No more than one operation, and remains more than two pulmonary nodules which pathological confirmed were MIA or AIS.
- at least one measurable lesion conforming to RECIST v1.1 standard was left after cryotherapy.
- male or female, age 18 to 75 years old.
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- the ECOG PS score was 0 or 1.
- expected survival is more than 12 weeks.
- functions of vital organs and bone marrow meet the following requirements: A. ANC ≥1.5× 109/L, PLT ≥100× 109/L, HGB ≥9 g/dL; B. TBIL ≤1.5 ULN, ALT and/or AST ≤2.5 ULN, ALB ≥2.8 g/dL; C. Cr ≤1.5× ULN, or creatinine clearance rate ≥40 mL/min
- subject and subject's sexual partner shall use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period.
- subject must sign theinformed consent.
Who cannot join
- patients with EGFR mutations and ALK rearrangement.
- cannot be treated with cryoablation: diffuse lesions in both lungs, extensive pleural metastasis with large amount of pleural effusion, tumor adjacent to mediastinal large vessels or surrounding large vessels.
- have previously received anti-pd-1, anti-pd-l1, anti-ctla-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or immune checkpoint pathways.
- received the following treatment Within four weeks before enrollment:
- received systemic anti-tumor therapy, such as chemotherapy, targeted therapy and immunotherapy;
- receive any investigational medication;
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- receive a large dose of immunosuppressive drugs (systemic glucocorticoid exceeding 10 mg/ temprednisone or its equivalent);
- receive live attenuated vaccine;
- major surgery or unhealed surgical wounds, ulcers, or fractures.
- known or suspected active autoimmune diseases (congenital or acquired).
- allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- allergy to any component of monoclonal antibody preparation.
- interstitial lung disease.
- suffering from other uncontrolled serious diseases, including but not limited to:
- severe infections in the active phase or with poor clinical control;
- HIV infection (HIV antibody positive);
- acute or chronic active hepatitis B (HBV DNA positive) or acute or chronic active hepatitis C (HCV antibody positive);
- active tuberculosis;
- grade iii-iv congestive heart failure (New York cardiology association classification), poorly controlled and clinically significant arrhythmia;
- uncontrolled arterial hypertension (systolic blood pressure ≥160mmHg or diastolic blood pressure ≥100mmHg);
- any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, occurred within 6 months;
- diseases requiring anticoagulant therapy with farfarin (coumarin);
- uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued bisphosphate therapy;
- accompanied by other malignant tumors (except those that have been cured, such as carcinoma in situ of the cervix, non-melanoma skin cancer, etc.).
- 10. The participants were judged to be unsuitable for the study by investigator.
- 11. Pregnant or nursing women.
Trial locations and contacts
No sites are listed yet.
Ming Liu, MD contact
About this study
Official title: An Exploratory Study on the Safety and Efficacy of Cryoablation Combined With Camrelizumab and Apatinib in the Treatment of Multiprimary Lung Cancer With Non-known Driving Genes
Objective: This study is to observe the safety and therapeutic effect of cryoablation combined with pd-1 antibody immunotherapy and anti-angiogenesis therapy in multiple primary lung cancer (MPLC) patients.
Methods: In this study, 20 patients with MPLC who conform to the admission criteria are enrolled and began to receive treatment with Camrelizumab combined with Apatinib after cryoablation.
Read the detailed description
Subjects who meet the admission criteria will be treated with Camrelizumab and Apatinib until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued.
The primary end point of this study is safety of cryoablation combined with carillizumab and apatinib for MPLC. The secondary endpoints include objective response rate, disease control rate, time to progression, progression free survival and overall survival. Exploratory endpoint is to explore biomarkers in tumor tissue and blood that could potentially predict the efficacy of Camrelizumab and Apatinib.
- Conditions
- Lung Cancer
- Being tested
- Camrelizumab and Apatinib
- Keywords
- MPLC, Camrelizumab, 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.
Camrelizumab and ApatinibDrug
Also called cryoablation
Camrelizumab, iv, Q3W; Apatinib, po, QD
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Camrelizumab, iv, Q3W until progression disease or intolerable toxicity or 2 years Apatinib, po, QD until progression disease or intolerable toxicity or 2 years Receives: Drug: Camrelizumab and Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety score
The occurrence of grade 3 to 5 adverse reactions was assessed by CTC AE v5.0
Measured: three weeks
Secondary outcomes (5)
ORR
objective response rate
Measured: six weeks
DCR
Disease control rate
Measured: six weeks
PFS
progression free survival
Measured: six weeks
OS
Overall survival
Measured: six weeks
DOR
Duration of response
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (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
- Model description
- About two to three weeks after cryoablation, Eligible patients sign informed consent and then begin treating with Camrelizumab and Apatinib.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ShiYue Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201990
- Sponsor's protocol ID
- 2019-62
- Acronym
- CCA-MPLC
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Safety and Efficacy of Cryoablation Combined With Camrelizumab and Apatinib in the Treatment of Multiprimary Lung Cancer With Non-known Driving Genes
- ClinicalTrials.gov ID
- NCT04201990
- Acronym / sponsor ID
- CCA-MPLC / 2019-62
- Conditions
- Lung Cancer
- Keywords
- MPLC, Camrelizumab, Apatinib
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ShiYue LiUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 Dec 2019 (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.
Objective: This study is to observe the safety and therapeutic effect of cryoablation combined with pd-1 antibody immunotherapy and anti-angiogenesis therapy in multiple primary lung cancer (MPLC) patients.
Methods: In this study, 20 patients with MPLC who conform to the admission criteria are enrolled and began to receive treatment with Camrelizumab combined with Apatinib after cryoablation.
Detailed description
Subjects who meet the admission criteria will be treated with Camrelizumab and Apatinib until disease progression, intolerable toxicity, death, withdrawal of the patient or the researchers determined that the drug must be discontinued.
The primary end point of this study is safety of cryoablation combined with carillizumab and apatinib for MPLC. The secondary endpoints include objective response rate, disease control rate, time to progression, progression free survival and overall survival. Exploratory endpoint is to explore biomarkers in tumor tissue and blood that could potentially predict the efficacy of Camrelizumab and Apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- About two to three weeks after cryoablation, Eligible patients sign informed consent and then begin treating with Camrelizumab and Apatinib.
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Camrelizumab and ApatinibCamrelizumab, iv, Q3W until progression disease or intolerable toxicity or 2 years Apatinib, po, QD until progression disease or intolerable toxicity or 2 years |
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 muitiple primary lung cancer.
- more than three pulmonary nodules and without lymph node metastasis.
- the maximum lesion less than three centimeters in diameter.
- No more than one operation, and remains more than two pulmonary nodules which pathological confirmed were MIA or AIS.
- at least one measurable lesion conforming to RECIST v1.1 standard was left after cryotherapy.
Key exclusion criteria (26 listed)
- patients with EGFR mutations and ALK rearrangement.
- cannot be treated with cryoablation: diffuse lesions in both lungs, extensive pleural metastasis with large amount of pleural effusion, tumor adjacent to mediastinal large vessels or surrounding large vessels.
- have previously received anti-pd-1, anti-pd-l1, anti-ctla-4 antibodies or any other antibodies or drugs that target T cell co-stimulation or immune checkpoint pathways.
- received the following treatment Within four weeks before enrollment:
- known or suspected active autoimmune diseases (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 |
|---|---|---|
| Camrelizumab and ApatinibAlso: cryoablationCamrelizumab, iv, Q3W; Apatinib, po, QD | Drug | treatment group |
Primary outcome
Safety score
Time frame: three weeks
The occurrence of grade 3 to 5 adverse reactions was assessed by CTC AE v5.0
5 secondary outcomes
ORR
Time frame: six weeks
DCR
Time frame: six weeks
PFS
Time frame: six weeks
OS
Time frame: six weeks
DOR
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
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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. This study is not recruiting at the moment.
Ming Liu, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Camrelizumab and Apatinib in people with Lung Cancer, run by ShiYue Li.
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 26 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: status not confirmed, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, MD (8620-83062896, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety score (time frame: three weeks). 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 17 Dec 2019.