Lung Squamous Cell CarcinomaPhase 4NCT03725423
Apatinib for Advanced Lung Squmamous Carcinoma
A Phase 4 study testing Apatinib in people with Lung Squamous Cell Carcinoma, run by Xuzhou Central Hospital.
Trial summary
In order to search for effective and low toxicity anti-tumor angiogenesis drugs, jiangsu hengrui pharmaceutical co., ltd. developed the high-efficiency VEGFR2 tyrosine kinase inhibitor apatinib. This drug is mainly used to treat malignant tumors by inhibiting VEGFR2 to play an anti-angiogenic role. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Squamous Cell Carcinoma
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: more than 18 years old;
- The pathology diagnosed late (Ⅲ B, Ⅳ) lung squamous cell carcinoma, with measurable lesion (tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher, scanning is not more than 5 mm, with a thick layer of measurable lesions not received radiotherapy, refrigeration, etc).
- Patients who have been treated with Eastern Cooperative Oncology Group for recurrence or failure of at least two-line standard treatment can be enrolled; Definition of "treatment failure" :(1) clear imaging or clinical evidence of disease progression during or after the last treatment; (2) could not be intolerance events out of the standard treatment by CTCAE 4.0 standard, the intolerance of adverse events mean acuity level Ⅳ hematology toxicity or acuity levels Ⅲ non hematologic toxicity or acuity Ⅱ heart, liver, kidney and other major organs damage.
- Eastern Cooperative Oncology Group score: 0-2;
- The predicted survival time is greater than or equal to 3 months;
- The damage caused by other treatments has been recovered (nci-ctcae version 4.0 grade is no more than 1), and the interval between receiving nitro-urea or mitomycin is no more than 6 weeks; Other cytotoxic drugs, Avastin, radiotherapy or surgery were performed for 4 weeks or longer. Eastern Cooperative Oncology Group TKI molecular targeted drugs were more than 2 weeks old;
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- Normal function of the main organs means that the following criteria are met:
- blood routine examination standards shall be met (no blood transfusions and blood products within 14 days, no g-csf and other hematopoietic stimulant correction is performed) :hb≥90 g / L;b . anc≥1.5×109 / L;c . plt≥80×109 / L; (2)biochemical test shall meet the following standards:
- total bilirubin<1.5upper limit of normal;
- ALT and AST<2.5upper limit of normal, and < 5upper limit of normal for patients with liver metastasis;
- Serum Cr is no more than 1.25upper limit of normal or Endogenous creatinine clearance rate > 45 ml/min (Cockcroft-Gault formula); 8. Women of childbearing age must have had access to reliable contraception or to a pregnancy test (serum or urine) within 7 days of enrollment with negative results and be willing to use an appropriate method of contraception eight weeks after the trial period and the last time the trial drug was administered. For men, consent should be given to use an appropriate method of contraception or surgical sterilization eight weeks after the trial period and the last administration of the drug; 9. The subjects voluntarily joined the study and signed the informed consent, with good compliance and followed up.
Who cannot join
- Cancer meningitis, spinal cord compression, or screening imaging CT or MRI found brain or pial meninges disease (21 days before the treatment and stable symptoms of brain metastases can be admitted to the group, but only through brain MRI, CT or venography were confirmed as anencephalic hemorrhage symptoms.
- Patients with symptomatic central nervous system metastasis.
- Imaging (CT or MRI) showed that the tumor focus was no more than 5 mm from the large blood vessels, or there was a central tumor invading the local large blood vessels.
- Uncontrolled hypertension (systolic blood pressure of 140mmhg or diastolic pressure of 90mmhg, despite the best drug treatment);
- Suffering from myocardial ischemia and myocardial infarction Ⅱ class above, poor control of arrhythmia (including QTc interphase male 450, female 470 ms or ms or higher);
- According to NYHA standard Ⅲ ~ Ⅳ cardiac insufficiency, or heart colour to exceed revealed left ventricular ejection fraction (LVEF) < 50%;
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- Abnormal coagulation function (INR >1.5 or prothrombin time (PT) > upper limit of normal+4 seconds or APTT >1.5upper limit of normal), with bleeding tendency or being treated with thrombolysis or anticoagulation;
- Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs; Note: under the premise that the internationally standardized ratio (INR) of prothrombin time is no more than 1.5, low doses of heparin (60 thousand to 12 thousand U per day for adults) or low doses of aspirin (no more than 100 mg per day) are allowed for preventive purposes.
- Significant hemoptysis, or hemoptysis, of half a teaspoon (2.5ml) or more per day within 2 months before enrollment;
- Bleeding symptoms with significant clinical significance or with definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood at baseline ++ and above, or with vasculitis, etc. appear within 3 months before enrollment;
- Arteriovenous thrombosis events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. occurred within 12 months before enrollment;
- Known hereditary or acquired bleeding and thrombotic tendencies (e.g., haemophiliacs, clotting disorders, thrombocytopenia, hypersplenism, etc.);
- Long term untreated wounds or fractures;
- Received major surgery or developed severe traumatic injury, fracture or ulcer within 4 weeks before enrollment;
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment;
- The routine urine test suggested that the urine protein was greater than or equal to ++, or the 24-hour urine protein was greater than or equal to 1.0g.
- Patients with active viral hepatitis b or c;
- Active infections that require antimicrobial treatment (e.g. antimicrobial, antiviral, antifungal);
- Persons who have a history of psychotropic drug abuse and are unable to quit or have mental disorders;
- Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
- Before entering into the group, I used the inhibitor of the Vascular epidermal growth factor (except bevacizumab);
- Previous or concurrent incurable malignancies, with the exception of cured basal cell carcinoma of the skin, in situ carcinoma of the cervix and superficial bladder cancer;
- Those who had been treated with strong CYP3A4 inhibitor within 7 days before enrollment, or who had been treated with strong CYP3A4 inducer within 12 days before participating in the study;
- Pregnant or lactating women; A person who is unable or unwilling to take effective contraceptive measures;
- The investigator identifies other conditions that may affect the conduct of clinical studies and the outcome of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Apatinib Mesylate Was Used in the Treament of Patients With Advanced Lung Squamous Cell Carcinoma of the Third Line and Above
In order to search for effective and low toxicity anti-tumor angiogenesis drugs, jiangsu hengrui pharmaceutical co., ltd. developed the high-efficiency VEGFR2 tyrosine kinase inhibitor apatinib. This drug is mainly used to treat malignant tumors by inhibiting VEGFR2 to play an anti-angiogenic role. Both in vivo and in vitro experiments have shown that apatinib has good tumor growth inhibition activity for lung cancer. This study aims to further confirm the effectiveness and safety of apatinib third-line treatment for patients with advanced lung squamous cell carcinoma.
Read the detailed description
Apatinib, 250mg, once a day (qd), take it half an hour after meal (the time for taking the medicine should be the same as possible), and take it with warm water. 28 days is a drug delivery cycle.According to the patient's condition, a single drug was selected for 6 cycles of chemotherapy in gemcitabine, yew and ruibin, changchun. After the chemotherapy, the single drug apatinib was maintained.Adverse reactions should be closely monitored during the use of apatinib and adjusted as needed to enable patients to tolerate treatment. The adverse reactions caused by apatinib can be treated by symptomatic treatment, drug withdrawal and dose adjustment. In clinical studies, dose adjustment usually occurs in the second and third cycles (28 days is one cycle). In case of 3/4 grade adverse reactions, the drug can be suspended until the toxic and side effects are completely recovered. Exit the study if 3/4 level of adverse reactions occur again after resumption of medication.
- Conditions
- Lung Squamous Cell Carcinoma
- Being tested
- Apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
250mg, qd once a day, take it half an hour after meal (the time for taking the medicine should be the same as possible), and take it with warm water. 28 days is a drug delivery cycle.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Oral administration of 250mg of apatinib daily, with or without chemotherapy Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respond Evaluation Criteria in Solid Tumors
Complete Response, partial response
Measured: Through study completion,an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Squamous Cell CarcinomaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Chunguang, Xuzhou Central Hospital
- Investigators
- Xiang Wang, Master, Principal investigator, Xuzhou central hospaital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725423
- Sponsor's protocol ID
- XuzhouCH
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Davies H, Hunter C, Smith R, Stephens P, Greenman C, Bignell G, Teague J, Butler A, Edkins S, Stevens C, Parker A, O'Meara S, Avis T, Barthorpe S, Brackenbury L, Buck G, Clements J, Cole J, Dicks E, Edwards K, Forbes S, Gorton M, Gray K, Halliday K, Harrison R, Hills K, Hinton J, Jones D, Kosmidou V, Laman R, Lugg R, Menzies A, Perry J, Petty R, Raine K, Shepherd R, Small A, Solomon H, Stephens Y, Tofts C, Varian J, Webb A, West S, Widaa S, Yates A, Brasseur F, Cooper CS, Flanagan AM, Green A, Knowles M, Leung SY, Looijenga LH, Malkowicz B, Pierotti MA, Teh BT, Yuen ST, Lakhani SR, Easton DF, Weber BL, Goldstraw P, Nicholson AG, Wooster R, Stratton MR, Futreal PA. Somatic mutations of the protein kinase gene family in human lung cancer. Cancer Res. 2005 Sep 1;65(17):7591-5. doi: 10.1158/0008-5472.CAN-05-1855.
PubMed 16140923
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apatinib Mesylate Was Used in the Treament of Patients With Advanced Lung Squamous Cell Carcinoma of the Third Line and Above
- ClinicalTrials.gov ID
- NCT03725423
- Acronym / sponsor ID
- XuzhouCH
- Conditions
- Lung Squamous Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Xuzhou Central HospitalUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 31 Oct 2018 (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.
In order to search for effective and low toxicity anti-tumor angiogenesis drugs, jiangsu hengrui pharmaceutical co., ltd. developed the high-efficiency VEGFR2 tyrosine kinase inhibitor apatinib. This drug is mainly used to treat malignant tumors by inhibiting VEGFR2 to play an anti-angiogenic role. Both in vivo and in vitro experiments have shown that apatinib has good tumor growth inhibition activity for lung cancer. This study aims to further confirm the effectiveness and safety of apatinib third-line treatment for patients with advanced lung squamous cell carcinoma.
Detailed description
Apatinib, 250mg, once a day (qd), take it half an hour after meal (the time for taking the medicine should be the same as possible), and take it with warm water. 28 days is a drug delivery cycle.According to the patient's condition, a single drug was selected for 6 cycles of chemotherapy in gemcitabine, yew and ruibin, changchun. After the chemotherapy, the single drug apatinib was maintained.Adverse reactions should be closely monitored during the use of apatinib and adjusted as needed to enable patients to tolerate treatment. The adverse reactions caused by apatinib can be treated by symptomatic treatment, drug withdrawal and dose adjustment. In clinical studies, dose adjustment usually occurs in the second and third cycles (28 days is one cycle). In case of 3/4 grade adverse reactions, the drug can be suspended until the toxic and side effects are completely recovered. Exit the study if 3/4 level of adverse reactions occur again after resumption of medication.
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: ApatinibOral administration of 250mg of apatinib daily, with or without chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: more than 18 years old;
- The pathology diagnosed late (Ⅲ B, Ⅳ) lung squamous cell carcinoma, with measurable lesion (tumor lesions on CT scan length to diameter 10 mm, or lymph node lesions on CT scans short diameter 15 mm or higher, scanning is not more than 5 mm, with a thick layer of measurable lesions not received radiotherapy, refrigeration, etc).
- Patients who have been treated with Eastern Cooperative Oncology Group for recurrence or failure of at least two-line standard treatment can be enrolled; Definition of "treatment failure" :(1) clear imaging or clinical evidence of disease progression during or after the last treatment; (2) could not be intolerance events out of the standard treatment by CTCAE 4.0 standard, the intolerance of adverse events mean acuity level Ⅳ hematology toxicity or acuity levels Ⅲ non hematologic toxicity or acuity Ⅱ heart, liver, kidney and other major organs damage.
- Eastern Cooperative Oncology Group score: 0-2;
- The predicted survival time is greater than or equal to 3 months;
Key exclusion criteria (26 listed)
- Cancer meningitis, spinal cord compression, or screening imaging CT or MRI found brain or pial meninges disease (21 days before the treatment and stable symptoms of brain metastases can be admitted to the group, but only through brain MRI, CT or venography were confirmed as anencephalic hemorrhage symptoms.
- Patients with symptomatic central nervous system metastasis.
- Imaging (CT or MRI) showed that the tumor focus was no more than 5 mm from the large blood vessels, or there was a central tumor invading the local large blood vessels.
- Uncontrolled hypertension (systolic blood pressure of 140mmhg or diastolic pressure of 90mmhg, despite the best drug treatment);
- Suffering from myocardial ischemia and myocardial infarction Ⅱ class above, poor control of arrhythmia (including QTc interphase male 450, female 470 ms or ms or higher);
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 |
|---|---|---|
| Apatinib250mg, qd once a day, take it half an hour after meal (the time for taking the medicine should be the same as possible), and take it with warm water. 28 days is a drug delivery cycle. | Drug | experimental group |
Primary outcome
Respond Evaluation Criteria in Solid Tumors
Time frame: Through study completion,an average of 1 year
Complete Response, partial response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Background: PubMed 16140923Davies H, Hunter C, Smith R, Stephens P, Greenman C, Bignell G, Teague J, Butler A, Edkins S, Stevens C, Parker A, O'Meara S, Avis T, Barthorpe S, Brackenbury L, Buck G, Clements J, Cole J, Dicks E, Edwards K, Forbes S, Gorton M, Gray K, Halliday K, Harrison R, Hills K, Hinton J, Jones D, Kosmidou V, Laman R, Lugg R, Menzies A, Perry J, Petty R, Raine K, Shepherd R, Small A, Solomon H, Stephens Y, Tofts C, Varian J, Webb A, West S, Widaa S, Yates A, Brasseur F, Cooper CS, Flanagan AM, Green A, Knowles M, Leung SY, Looijenga LH, Malkowicz B, Pierotti MA, Teh BT, Yuen ST, Lakhani SR, Easton DF, Weber BL, Goldstraw P, Nicholson AG, Wooster R, Stratton MR, Futreal PA. Somatic mutations of the protein kinase gene family in human lung cancer. Cancer Res. 2005 Sep 1;65(17):7591-5. doi: 10.1158/0008-5472.CAN-05-1855.
- Individual participant dataSharing planned: Undecided
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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.
Xiang Wang, Master principal investigator
Xuzhou central hospaital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apatinib in people with Lung Squamous Cell Carcinoma, run by Xuzhou Central Hospital.
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 31 Oct 2018. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xiang Wang, Master (18112007602, tyx876@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respond Evaluation Criteria in Solid Tumors (time frame: Through study completion,an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725423, which also lists 1 linked publication.
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 31 Oct 2018.