Small Cell Lung CancerPhase 2NCT04128800
Appatinib Combined With S-1 in the Treatment of Small Cell Lung Cancer
A Phase 2 study testing Apatinib S-1 in people with Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Apatinib S-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2019to Dec 2021
- Phase
- Phase 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
- The informed consent of the patient must be obtained before any research steps are carried out.
- Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
- Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
- Male or female subjects > 18 years old, < 75 years old
- There are objective lesions that can be measured by CT.
- The activity status of KPS was above 80 points.
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- Within 14 days before admission, the bone marrow, liver and kidney functions detected by the central laboratory should meet the following laboratory data requirements:
- Hemoglobin ≥ 9.0 g/dl; absolute neutrophil count (ANC)1,500 /mm3 ; platelet count ≥ 50,000 /ul; total bilirubin < 2 mg/dL (3 mg/dL, Child B); ALT and AST < 5-fold normal value upper limit; alkaline phosphatase < 4-fold normal value upper limit; PT > 50% or PT-INR < 2.3, or greater than the control value < 6 seconds.
- For subjects taking warfarin, the subjects were closely monitored at least once a week until the INR measurement of the subjects was stable at the time of each administration according to the local treatment standards.
- The upper limit of normal serum creatinine < 1.5 times is
- For pregnant women, the results of serum pregnancy test must be negative within 14 days before the start of treatment.
- All male and female patients participating in this study must adopt reliable contraceptive measures during the trial and within two week.
Who cannot join
- KPS < 60 points, or expected survival < 3 months.
- Severe cardiovascular diseases .
- Uncontrollable hypertension .
- History of human immunodeficiency virus (HIV) infection .
- Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
- Epilepsy patients requiring medication (e.g. steroids or antiepileptic drugs) .
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- History of allogeneic organ transplantation .
- Patients with signs of hemorrhage or history of disease.
- Patients undergoing renal dialysis.
- Chronic obstructive pulmonary emphysema .
- Gastrointestinal bleeding within 30 days before admission .
- Patients have a history of esophageal varices bleeding, and subsequently did not receive effective treatment or treatment to prevent recurrence of bleeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Ning bo Liu, MD, 15822117210, liuningbo@tjmuch.com
Ping Wang, MD, 18622221112, wangping99999@yahoo.com
About this study
Official title: A Single-center, Single-arm Exploratory Clinical Study of Apatinib Mesylate Tablets Combined With S-1 in the Treatment of Second-line or More Advanced Small Cell Lung Cancer
To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy
Read the detailed description
Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.
Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.
In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Apatinib S-1
- Keywords
- apatinib S-1, Advanced lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib S-1Drug
Also called apatinib mesylate tablets
apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib and S-1 group | Experimental | Not described Receives: Drug: Apatinib S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Measured: one year
Secondary outcomes (1)
Disease Control Rate (DCR)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning bo Liu, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128800
- Sponsor's protocol ID
- AHEAD-HBH
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Single-arm Exploratory Clinical Study of Apatinib Mesylate Tablets Combined With S-1 in the Treatment of Second-line or More Advanced Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04128800
- Acronym / sponsor ID
- AHEAD-HBH
- Conditions
- Small Cell Lung Cancer
- Keywords
- apatinib S-1, Advanced lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Oct 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.
To evaluate the objective remission rate and disease control rate of apatinib mesylate tablets combined with S-1 in the treatment of advanced small cell lung cancer patients with failed or dangerous radiotherapy or chemotherapy
Detailed description
Lung cancer is one of the malignant tumors with the highest morbidity and mortality in the world. Small cell lung cancer accounts for about 15-20% of all lung cancer. Although the initial treatment is sensitive to radiotherapy and chemotherapy, patients with small cell lung cancer are prone to recurrence and metastasis in the early stage, and ultimately lead to death due to the lack of effective treatment after the disease progresses. Patients with relapsed small cell lung cancer had a poor prognosis; untreated patients had only two to three months of expected survival.Therefore, it is urgent to find a method to treat SCLC.
Two single-arm phase II clinical studies on small cell lung cancer have evaluated the efficacy and safety of bevacizumab combined with first-line chemotherapy for extensive SCLC. Two phase II single arm studies showed good efficacy and safety. Apatinib and bevacizumab are both antiangiogenic agents. S-1 is a new oral fluoropyrimidine anticancer agent, but S-1 has shown a high remission rate for metastatic NSCLC and relapsed NSCLC.
In view of the good efficacy and tolerability of oral chemotherapeutic agent S-1, and the lack of suitable targeted drugs after NGS treatment in relapsed S LCL patients after previous multithreaded treatment, this clinical trial is to study the efficacy and safety of combination of anti-angiogenesis drugs and S-1 in patients with failed or dangerous SCLC after second-line or more radiotherapy and chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib and S-1 group | Experimental | Drug: Apatinib S-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The informed consent of the patient must be obtained before any research steps are carried out.
- Confirmation of SCLC: Histological diagnosis or two imaging diagnoses must be made.
- Late stage of SCLC, failure of second-line radiotherapy and chemotherapy or dangerous type of patients
- Male or female subjects > 18 years old, < 75 years old
- There are objective lesions that can be measured by CT.
Key exclusion criteria (12 listed)
- KPS < 60 points, or expected survival < 3 months.
- Severe cardiovascular diseases .
- Uncontrollable hypertension .
- History of human immunodeficiency virus (HIV) infection .
- Active clinical severe infections (Grade 2, NCI-CTCAE Version 3.0) .
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 |
|---|---|---|
| Apatinib S-1Also: apatinib mesylate tabletsapatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle. | Drug | Apatinib and S-1 group |
Primary outcome
Objective Response Rate(ORR)
Time frame: one year
1 secondary outcome
Disease Control Rate (DCR)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Individual participant dataSharing planned: Yes
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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.
Ning bo Liu, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib S-1 in people with Small Cell Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital 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 12 inclusion and 12 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 16 Oct 2019. 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 phase mean?
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 Ning bo Liu, MD (15822117210, liuningbo@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: one year). 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 16 Oct 2019.