Advanced Gastric CancerNCT03255811
Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer
A study testing apatinib in people with Advanced Gastric Cancer, run by DongMa at 1 site in China.
Trial summary
At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Advanced Gastric Cancer
- 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2017to 25 Mar 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age: more than 18 years old, male or female;
- histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma, stomach with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST standard 1.1);
- inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or esophagogastric junction;
- first-line chemotherapy (oxaliplatin / cisplatin / paclitaxel combined with fluorouracil / either drug, docetaxel or S-1 / capecitabine), efficacy evaluation of SD or CR or PR may, from the last chemotherapy cycle time is not more than 28 days;
- when evaluating the maximum response rate of chemotherapy (chemotherapy is not less than 4 cycles), enter maintenance therapy. (maximum response rate: compared with the previous curative effect evaluation, the target lesion no longer continued to shrink);
- ECOG PS:0-1 points;
Show all 13Show fewer
- baseline blood routine and biochemical parameters met the following criteria: Hemoglobin is larger than 80g/L,
- the absolute neutrophil count (ANC) = 1.5 * 109/L, Over 90 * 109/L platelets,
- ALT, AST less than 2.5 times the upper limit of normal value, Equal to or less than 5 times the upper limit of normal (liver metastasis),
- the serum total bilirubin is less than 1.5 times the upper limit of normal value, Serum creatinine. Less than 1.5 times the upper limit of normal value, Serum albumin is more than 30g/L;
- more than the expected survival time in March;
- women of childbearing age must have pregnancy tests (serum or urine) within 7 days prior to admission, and the results are negative and are willing to take the appropriate method of contraception at 8 weeks after the trial and at the end of the test. For men, surgical sterilization should be applied, or consent to the appropriate method of contraception 8 weeks after the trial and at the end of the trial;
- subjects voluntarily joined the study, signed informed consent, good compliance, and followed up.
Who cannot join
- confirmed of apatinib and / or its accessories allergy;
- with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (>140 systolic blood pressure mmHg, diastolic blood pressure >90 mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc prolongation > 450 male MS, female MS > 470) and grade I heart function insufficiency; patients with positive urinary protein;
- , there are a variety of factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); The 4. has a clear tendency in patients with gastrointestinal bleeding, including the following: local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2 months melena, hematemesis history; for fecal occult blood (+) and gastric primary tumor without surgical resection. And for gastroscopy, such as gastric cancer, and researchers believe that may occur in massive hemorrhage of digestive tract were;
- 5. coagulation dysfunction (INR>1.5, APTT>1.5, ULN), with bleeding tendency; 6. patients with central nervous system metastasis; 7. pregnant or lactating women; A patient with other malignancies within 8.5 years; 9. patients who have history of psychotropic substance abuse and are unable to quit or have mental disorders; Patients who participated in other clinical trials within 10.4 weeks; 11. received VEGFR inhibitors, such as Sola Fini and sunitinib therapy; 12. according to the researcher's judgment, there are patients who seriously endanger the safety of patients or affect the patients who complete the study; 13., the researchers considered unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer -- Multicenter, Open, One Arm Exploratory Study
At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
Read the detailed description
The incidence of gastric cancer in China is high, and there is no standard first-line chemotherapy regimen for advanced gastric cancer. Second-line therapy usually involves first-line treatment, without the use of drugs for combination or monotherapy, and no uniform treatment. Apatinib approved provides a good solution to this problem, but this study is in limit of validity standard after all into the row, not very good reaction in clinical practice for APA imatinib reality in the treatment of advanced gastric cancer. Therefore, it is necessary to make a prospective product study to understand the gap between clinical practice and research results. This study can evaluate apatinib in treatment of advanced gastric or gastroesophageal junction safe and effective parts of adenocarcinoma in clinical practice, and the specific usage (such as dose and period). The results of this study can help the future clinical practice specification of apatinib parts for the treatment of adenocarcinoma with advanced gastric or gastroesophageal reflux, the advanced gastric or gastroesophageal adenocarcinoma patients with parts get treatment more safe and effective in the treatment of.
At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
- Conditions
- Advanced Gastric Cancer
- Being tested
- apatinib
- Keywords
- Advanced gastric cancer apatinib Maintenance therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
Apatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival.
| Study group | Role | What they receive |
|---|---|---|
| The dosage regimen | Experimental | The chemotherapy response rate reached the maximum after 14-28 days, apatinib, 750 mg (QD), once a day, half an hour after meal (daily dosing time should be as same as possible), with warm boiling water delivery service. 28 days for a dosing cycle. Receives: Drug: apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma
Progression free survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start25 Mar 2017
- Primary completion25 Jan 2019 (estimated)
- Study completion25 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DongMa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DongMa, Guangdong Provincial People's Hospital
- Investigators
- Ma Dong, graduate, Study director, Leading Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255811
- Sponsor's protocol ID
- Gastrointestinal cancer
- Status last verified
- Aug 2017
- First submitted
- 17 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Treatment of Apatinib Mesylate in First-line Maintenance of Advanced Gastric Cancer -- Multicenter, Open, One Arm Exploratory Study
- ClinicalTrials.gov ID
- NCT03255811
- Acronym / sponsor ID
- Gastrointestinal cancer
- Conditions
- Advanced Gastric Cancer
- Keywords
- Advanced gastric cancer apatinib Maintenance therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- DongMaUniversity, hospital or other
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 25 Jan 2019 (estimated)
- Study completion
- 25 Mar 2019 (estimated)
- First posted
- 21 Aug 2017 (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.
At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
Detailed description
The incidence of gastric cancer in China is high, and there is no standard first-line chemotherapy regimen for advanced gastric cancer. Second-line therapy usually involves first-line treatment, without the use of drugs for combination or monotherapy, and no uniform treatment. Apatinib approved provides a good solution to this problem, but this study is in limit of validity standard after all into the row, not very good reaction in clinical practice for APA imatinib reality in the treatment of advanced gastric cancer. Therefore, it is necessary to make a prospective product study to understand the gap between clinical practice and research results. This study can evaluate apatinib in treatment of advanced gastric or gastroesophageal junction safe and effective parts of adenocarcinoma in clinical practice, and the specific usage (such as dose and period). The results of this study can help the future clinical practice specification of apatinib parts for the treatment of adenocarcinoma with advanced gastric or gastroesophageal reflux, the advanced gastric or gastroesophageal adenocarcinoma patients with parts get treatment more safe and effective in the treatment of.
At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At present, apatinib was approved for the treatment of advanced gastric cancer after second-line or gastroesophageal junction adenocarcinoma, is in the second one, experience of medication, clinical data, no chemotherapy so now intends to carry out 40 cases of small sample exploratory research, in the conventional chemotherapy after the onset, with APA for Nigeria maintenance treatment, with a preliminary understanding of apatinib in first-line advanced gastric cancer to maintain the efficacy and safety of the treatment, and explore the feasibility of anti generate small molecule targeted therapy in advanced gastric cancer vascular pattern.
| Arm | Type | Receives |
|---|---|---|
| The dosage regimen | Experimental | Drug: apatinibThe chemotherapy response rate reached the maximum after 14-28 days, apatinib, 750 mg (QD), once a day, half an hour after meal (daily dosing time should be as same as possible), with warm boiling water delivery service. 28 days for a dosing cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- age: more than 18 years old, male or female;
- histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma, stomach with measurable lesions (spiral CT scan is more than 10mm, meet the RECIST standard 1.1);
- inoperable, locally advanced, recurrent or metastatic adenocarcinoma of the stomach or esophagogastric junction;
- first-line chemotherapy (oxaliplatin / cisplatin / paclitaxel combined with fluorouracil / either drug, docetaxel or S-1 / capecitabine), efficacy evaluation of SD or CR or PR may, from the last chemotherapy cycle time is not more than 28 days;
- when evaluating the maximum response rate of chemotherapy (chemotherapy is not less than 4 cycles), enter maintenance therapy. (maximum response rate: compared with the previous curative effect evaluation, the target lesion no longer continued to shrink);
Key exclusion criteria (4 listed)
- confirmed of apatinib and / or its accessories allergy;
- with high blood pressure and the antihypertensive drug treatment can not be reduced to the normal range (>140 systolic blood pressure mmHg, diastolic blood pressure >90 mmHg), with I level above grade I coronary heart disease, arrhythmia (including QTc prolongation > 450 male MS, female MS > 470) and grade I heart function insufficiency; patients with positive urinary protein;
- , there are a variety of factors that affect oral medication (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); The 4. has a clear tendency in patients with gastrointestinal bleeding, including the following: local active ulcerative lesions, and fecal occult blood (+ +) can not be enrolled; 2 months melena, hematemesis history; for fecal occult blood (+) and gastric primary tumor without surgical resection. And for gastroscopy, such as gastric cancer, and researchers believe that may occur in massive hemorrhage of digestive tract were;
- 5. coagulation dysfunction (INR>1.5, APTT>1.5, ULN), with bleeding tendency; 6. patients with central nervous system metastasis; 7. pregnant or lactating women; A patient with other malignancies within 8.5 years; 9. patients who have history of psychotropic substance abuse and are unable to quit or have mental disorders; Patients who participated in other clinical trials within 10.4 weeks; 11. received VEGFR inhibitors, such as Sola Fini and sunitinib therapy; 12. according to the researcher's judgment, there are patients who seriously endanger the safety of patients or affect the patients who complete the study; 13., the researchers considered unsuitable for inclusion.
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 |
|---|---|---|
| apatinibApatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival. | Drug | The dosage regimen |
Primary outcome
Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma
Time frame: 2 years
Progression free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
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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.
Ma Dong, graduate study director
Leading Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing apatinib in people with Advanced Gastric Cancer, run by DongMa 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 13 inclusion and 4 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 21 Aug 2017. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of apatinib mesylate tablets as first-line maintenance treatment for advanced gastric or gastroesophageal junction progression free survival site adenocarcinoma (time frame: 2 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 21 Aug 2017.