Gastric CancerPhase 4NCT02776527
A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
A Phase 4 study testing Apatinib Mesylate Tablets in people with Gastric Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The main purpose of this study is to evaluate whether the Apatinib can improve the disease free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed postoprative adjuvant chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib Mesylate Tablets
- 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
- Apr 2016to Apr 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of patients ranges from 18 to75 years old.
- Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2.
- All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen.
- Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy.
- Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox.
- Previously, patients did not receive the therapy of Apatinib or other VEGFR inhibitor, such as Sorafenib, Sunitinib.
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- The blood examination is normal: neutrophil count≥1.5×109/L；hemoglobin≥80 g/L；blood platelet count≥100×109/L；total bilirubin≤1.5×ULN；ALT、AST≤2.5×ULN；
- Patients have no serious heart, lung, liver, kidney diseases and jaundice and digestive tract obstruction. Patients have no an acute infection.
- -
Who cannot join
- The score of KPS<60 or anticipated survival time<3 months.
- Previously, patients received neoadjuvant chemotherapy.
- Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein.
- Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months.
- Coagulopathy (INR>1.5、APTT>1.5 ULN), hemorrhage tendency.
- Patients have these symptoms, such as dysphagia, nausea, vomiting, chronic diarrhea and intestinal obstruction.
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- Patients have these symptoms, such as neurological diseases, mental illness, serious infection.
- Patients were pregnant, in nursing, or have bearing requirement during the study period.
- Patients got other primary malignant tumors (except curable skin basal cell carcinoma and cervical cancer in situ) except gastric cancer within 5 years.
- Patients have distant metastasis.
- Within 6 months before study starts and in the process of this study, patients participate in other clinical researches.
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastrointestinal Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Liang Han, Master, 086-022-23340123 ext. 1061, tjlianghan@126.com
About this study
The main purpose of this study is to evaluate whether the Apatinib can improve the disease free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether the Apatinib can improve the overall survival (OS), estimate the quality of life of patients have taken the Apatinib and monitor the security of Apatinib.
Read the detailed description
The investigators will recruit 40 gastric cancer patients who underwent D2 lymphadenectomy and histologically verified as stage ⅢB or ⅢC according to the seventh edition of the TNM classification for gastric cancer. When these patients have completed 8 cycles of Xelox as adjuvant chemotherapy without any recurrence, they will randomly assigned to group A or B. Each group possesses 20 gastric cancer patients finally. Patients in group A will receive the best supportive care，and take Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses. Patients in group B will receive the best supportive care. Through follow-up and statistics, the investigators will observe whether Apatinib can improve the disease free survival (DFS) of gastric cancer patients with stage IIIb\&IIIC. Meanwhile, the investigators also will observe whether the Apatinib can improve the overall survival (OS) and estimate the quality of life of patients have taken the Apatinib.
- Conditions
- Gastric Cancer
- Being tested
- Apatinib Mesylate Tablets
- Keywords
- Gastric cancer, D2 Lymphadenectomy, postoprative adjuvant chemotherapy, Apatinib, disease free survival
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib Mesylate TabletsDrug
Also called AiTan
taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
| Study group | Role | What they receive |
|---|---|---|
| A group | Experimental | D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses. Receives: Drug: Apatinib Mesylate Tablets |
| B group | No intervention | D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
Measured: 2 years
Secondary outcomes (1)
overall survival
Overall survival (OS) was defined as the length of time from the date of randomization to the date of death of various reasons
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 posted18 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Han Liang, Master, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776527
- Sponsor's protocol ID
- AHEAD-HBG001
- Status last verified
- Apr 2016
- First submitted
- 15 May 2016
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Maintenance Treatment of Apatinib in Advanced Gastric Cancer Patients Have Completed Postoprative Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT02776527
- Acronym / sponsor ID
- AHEAD-HBG001
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, D2 Lymphadenectomy, postoprative adjuvant chemotherapy, Apatinib, disease free survival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 18 May 2016 (estimated)
- 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 main purpose of this study is to evaluate whether the Apatinib can improve the disease free survival (DFS) of gastric cancer patients in stage IIIB/IIIc, who had completed postoprative adjuvant chemotherapy. Meanwhile, the investigators also will evaluate whether the Apatinib can improve the overall survival (OS), estimate the quality of life of patients have taken the Apatinib and monitor the security of Apatinib.
Detailed description
The investigators will recruit 40 gastric cancer patients who underwent D2 lymphadenectomy and histologically verified as stage ⅢB or ⅢC according to the seventh edition of the TNM classification for gastric cancer. When these patients have completed 8 cycles of Xelox as adjuvant chemotherapy without any recurrence, they will randomly assigned to group A or B. Each group possesses 20 gastric cancer patients finally. Patients in group A will receive the best supportive care，and take Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses. Patients in group B will receive the best supportive care. Through follow-up and statistics, the investigators will observe whether Apatinib can improve the disease free survival (DFS) of gastric cancer patients with stage IIIb\&IIIC. Meanwhile, the investigators also will observe whether the Apatinib can improve the overall survival (OS) and estimate the quality of life of patients have taken the Apatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A group | Experimental | Drug: Apatinib Mesylate TabletsD2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox,and taking Apatinib 500mg/qd orally, 28 days as a cycle, till disease progresses. |
| B group | No intervention | –D2 Radical Gastrectomy adding received postoprative adjuvant chemotherapy of eight cycles of Xelox |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of patients ranges from 18 to75 years old.
- Score of the Eastern Cooperative Oncology Group (ECOG) performance status ranges from 0 to 2.
- All tumor tissues were histologically verified as advanced gastric cancer, and patients with no less than 15 dissected lymph nodes and stage of ⅢB or ⅢC according to TNM, were chosen.
- Gastric cancer patients underwent the curative gastrectomy with D2 lymphadenectomy.
- Gastric cancer patients received postoprative adjuvant chemotherapy of eight cycles of Xelox. During the period of chemotherapy, no one relapses. If the patients could well tolerate the adjuvant chemotherapy, it is recommended that patients can obtain maintenance treatment of Apatinib after postoprative adjuvant chemotherapy of eight cycles of Xelox.
Key exclusion criteria (12 listed)
- The score of KPS<60 or anticipated survival time<3 months.
- Previously, patients received neoadjuvant chemotherapy.
- Within six months, patients encountered heart cerebral disease, got an uncontrolled hypertension (systolic blood pressure>140 mmHg, diastolic blood pressure>90 mmHg), had serious coronary heart disease, serious arrhythmia, first-grade cardiac insufficiency. Patients have positive urinary protein.
- Patients have clear gastrointestinal bleeding tendency, local active ulcer lesions, fecal occult blood (++); Patients have the symptoms of melena and haematemesis within 2 months.
- Coagulopathy (INR>1.5、APTT>1.5 ULN), hemorrhage tendency.
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 Mesylate TabletsAlso: AiTantaking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses | Drug | A group |
Primary outcome
disease free survival
Time frame: 2 years
Disease free survival (DFS) was defined as the length of time from the date of randomization to the date of first documentation of relapse of gastric cancer or any other type of cancer or death.
1 secondary outcome
overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
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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.
Han Liang, Master 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 4 study testing Apatinib Mesylate Tablets in people with Gastric 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 9 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 20 May 2016. 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 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 Han Liang, Master (086-022-23340123 ext. 1061, tjlianghan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (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 20 May 2016.