Gastric CancerPhase 2NCT03219593
Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer
A Phase 2 study testing Apatinib mesylate tablets in people with Gastric Cancer and Apatinib, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Gastric Cancer, Apatinib, Biomarker
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2017to Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Age ≥ 65 years;
- ECOG Performance Status: 0-2;
- No previous anti-cancer therapy for the locally advanced or metastatic disease;
- Unable or unwilling to chemotherapy;
- At least one measurable lesion as defined by RECIST 1.1;
Show all 9Show fewer
- With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
- Can take apatinib orally;
- Life Expectancy: 3 months or more.
Who cannot join
- History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
- Patients with un-controlled blood pressure on medication (> 140/90 mmHg);
- Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
- Patients with massive hydrothorax or ascites;
- Patients with uncontrolled central nervous system (CNS) metastases;
Show all 12Show fewer
- Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
- History of drug addiction or abuse;
- Patients cannot take apatinib orally for any reason;
- Estimated life expectancy ˂ 3 months;
- Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials;
- Inability to understand and agree to informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Yan Yang, M.D., Ph.D., +86-552-3086178, qiannianhupo@163.com
Qiong Wu, M.D., Ph.D.
About this study
Official title: A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.
- Conditions
- Gastric Cancer, Apatinib, Biomarker
- Being tested
- Apatinib mesylate tablets
- 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
Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Group | Experimental | take apatinib orally (500mg/d, once a day, continuously) Receives: Drug: Apatinib mesylate tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.
Measured: 1 year
Secondary outcomes (5)
Overall survival (OS)
OS was defined to be the time from registration to the date of death resulting from any cause or the last contact.
Measured: 2 years
Disease control rate (DCR)
DCR was defined as the proportion of patients who achieved complete response (CR ), partial response (PR) and stable disease (SD) for at least 8 weeks.
Measured: 1 year
Objective response rate (ORR)
ORR was defined as the proportion of eligible patients who achieved a confirmed CR or PR by RECIST 1.1 criteria evaluated by the investigators.
Measured: 1 year
Quality of life score (QoL)
QoL is a questionnaire developed to assess the quality of life of cancer patients.
Measured: 1 year
Adverse Events(AEs)
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start7 Sep 2017
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (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.
- 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
- Model description
- Apatinib Monotherapy
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yang, MD, Ph.D, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Qiong Wu, M.D.,Ph.D, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219593
- Sponsor's protocol ID
- BYEC20170710
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2017
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of the Efficacy and Safety of Apatinib Monotherapy as First-Line Treatment in Elderly Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT03219593
- Acronym / sponsor ID
- BYEC20170710
- Conditions
- Gastric Cancer, Apatinib, Biomarker
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Jul 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.
The study is to investigate the efficacy and safety of apatinib for the first-fine treatment in elderly patients with locally advanced or metastatic adenocarcinoma of stomach or gastroesophageal junction, unable or unwilling to chemotherapy, through progression-free survival (PFS). Apatinib will be given to patients with an efficacy assessment of stable disease (SD), partial response (PR), or complete response (CR) every 2 cycles. Patients were assigned to 500 mg/d apatinib continually until disease progression or intolerable toxicity or patients withdrawal of consent. The dose of apatinib may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg, and the sample size is about 30 individuals. Tumor tissue samples will be collected from each enrolled subjects before the start of treatment, and detected using next generation sequencing (NGS)-based comprehensive genomic profiling. The potential biomarkers in predicting apatinib efficacy or safety will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Apatinib Monotherapy
| Arm | Type | Receives |
|---|---|---|
| Apatinib Group | Experimental | Drug: Apatinib mesylate tabletstake apatinib orally (500mg/d, once a day, continuously) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Patients with histologically proven primary locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma;
- Age ≥ 65 years;
- ECOG Performance Status: 0-2;
- No previous anti-cancer therapy for the locally advanced or metastatic disease;
- Unable or unwilling to chemotherapy;
Key exclusion criteria (12 listed)
- History of other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ);
- Patients with un-controlled blood pressure on medication (> 140/90 mmHg);
- Patients with other nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases;
- Patients with bleeding tendency, receiving thrombolytics or anticoagulants；
- Patients with massive hydrothorax or ascites;
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 tabletsApatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg. | Drug | Apatinib Group |
Primary outcome
Progression-free survival (PFS)
Time frame: 1 year
PFS was defined to be the time from registration to the date of disease progression or death resulting from any cause.
5 secondary outcomes
Overall survival (OS)
Time frame: 2 years
Disease control rate (DCR)
Time frame: 1 year
Objective response rate (ORR)
Time frame: 1 year
Quality of life score (QoL)
Time frame: 1 year
Adverse Events(AEs)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Qiong Wu, M.D.,Ph.D principal investigator
The First Affiliated Hospital of Bengbu Medical University
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 mesylate tablets in people with Gastric Cancer and Apatinib, run by The First Affiliated Hospital of Bengbu Medical University 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yang, M.D.,Ph.D (+86-552-3086178, qiannianhupo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 1 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 8 Sep 2026.