Gastroesophageal Junction AdenocarcinomaPhase 2NCT03349866
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
A Phase 2 study testing apatinib, Capecitabine and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei Medical University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- apatinib, Capecitabine and Oxaliplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2017to 30 Nov 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age:18 to 70 years old (man or female);
- Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;
- Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
- Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Major organ function has to meet the following certeria:
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- HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; ALT and AST≤2.5×ULN, but<≤5×ULN if the transferanse elevation is due to liver metastases； TBIL<1.5×ULN； Serum creatinine ≤1.5×ULN;
- Life expectancy greater than or equal to 6 months;
- Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 7 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks;
- Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Who cannot join
- Allergic to apatinib, capecitabine and oxaliplatin;
- The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,classⅢ-Ⅳcardiac insufficiency;
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
- Coagulant function abnormality (INR > 1.5 ULN, APTT > 1.5 ULN), with bleeding tendency;
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- Pregnant or lactating women;
- Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
- History of psychiatric drugs abuse and can't quit or patients with mental disorders;
- Less than 4 weeks from the last clinical trial;
- The researchers think inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Qun Zhao, 13930162111, Zhaoqun516@126.com
About this study
The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Being tested
- apatinib, Capecitabine, Oxaliplatin, Radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apatinibDrug
apatinib：250mg qd po
CapecitabineDrug
1000mg/m2 bid d1-14
OxaliplatinDrug
130 mg/m2 Ivgtt d1 q3w
RadiotherapyRadiation
45Gy/25f （1.8Gy/f/d，5 f/w）
| Study group | Role | What they receive |
|---|---|---|
| apatinib XELOX and radiotherapy | Experimental | apatinib：250mg qd po XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） Receives: Drug: apatinib; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy |
| XELOX and radiotherapy | Active comparator | XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） Receives: Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pathological complete response rate(pCR)
The lesion disappeared completely by pathology
Measured: within 3 weeks after surgery
Secondary outcomes (5)
Objective response rate (ORR)
Baseline to measured stable disease
Measured: within 3 weeks after surgery
R0-resection rate
There was no residual by the microscope
Measured: within 3 weeks after surgery
Disease-free survival(DFS)
Baseline to measured date of recurrence or death from any cause
Measured: 3 year
Overall survival (OS)
Baseline to measured date of death from any cause
Measured: 3years
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.The number of Participants with adverse events will be recorded at each treatment visit.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start30 Nov 2017
- Primary completion30 Nov 2019
- Study completion30 Nov 2020 (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 Gastroesophageal Junction AdenocarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qun Zhao, Hebei Medical University
- Investigators
- Qun Zhao, Principal investigator, Hebei Medical University Fourth HospitalJun Wang, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349866
- Sponsor's protocol ID
- HRA-G01
- Status last verified
- Feb 2020
- First submitted
- 17 Nov 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo H, Li Y, Lin C, Cheng Y, Zhang Z, Wang D, Zhao X, Liu Y, Jing S, Yang P, Tian Y, Liu Y, Wang J, Zhao Q. Efficacy and safety of neoadjuvant chemoradiotherapy plus apatinib for patients with locally advanced, HER2-negative, Siewert's type II-III adenocarcinoma of esophagogastric junction: a single-arm, open-label, phase II trial. Am J Transl Res. 2021 Aug 15;13(8):9015-9023. eCollection 2021.
PubMed 34540013
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
- ClinicalTrials.gov ID
- NCT03349866
- Acronym / sponsor ID
- HRA-G01
- Conditions
- Gastroesophageal Junction Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hebei Medical UniversityUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 22 Nov 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 purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 negative adenocarcinoma at gastroesophageal junction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apatinib XELOX and radiotherapy | Experimental | Drug: apatinib, Drug: Capecitabine, Drug: Oxaliplatin, Radiation: Radiotherapyapatinib：250mg qd po XELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） |
| XELOX and radiotherapy | Active comparator | Drug: Capecitabine, Drug: Oxaliplatin, Radiation: RadiotherapyXELOX：Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w Radiotherapy：45Gy/25f （1.8Gy/f/d，5 f/w） |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age:18 to 70 years old (man or female);
- Confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy and CT, The her-2 negative was detected by immunohistochemistry;
- Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
- Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Key exclusion criteria (11 listed)
- Allergic to apatinib, capecitabine and oxaliplatin;
- The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
- Have high blood pressure and antihypertensive drug treatment can not control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg), Uncontrolled coronary heart disease and arrhythmia ,classⅢ-Ⅳcardiac insufficiency;
- A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
- Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
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：250mg qd po | Drug | apatinib XELOX and radiotherapy |
| Capecitabine1000mg/m2 bid d1-14 | Drug | XELOX and radiotherapy, apatinib XELOX and radiotherapy |
| Oxaliplatin130 mg/m2 Ivgtt d1 q3w | Drug | XELOX and radiotherapy, apatinib XELOX and radiotherapy |
| Radiotherapy45Gy/25f （1.8Gy/f/d，5 f/w） | Radiation | XELOX and radiotherapy, apatinib XELOX and radiotherapy |
Primary outcome
The pathological complete response rate(pCR)
Time frame: within 3 weeks after surgery
The lesion disappeared completely by pathology
5 secondary outcomes
Objective response rate (ORR)
Time frame: within 3 weeks after surgery
R0-resection rate
Time frame: within 3 weeks after surgery
Disease-free survival(DFS)
Time frame: 3 year
Overall survival (OS)
Time frame: 3years
Adverse events
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 34540013Guo H, Li Y, Lin C, Cheng Y, Zhang Z, Wang D, Zhao X, Liu Y, Jing S, Yang P, Tian Y, Liu Y, Wang J, Zhao Q. Efficacy and safety of neoadjuvant chemoradiotherapy plus apatinib for patients with locally advanced, HER2-negative, Siewert's type II-III adenocarcinoma of esophagogastric junction: a single-arm, open-label, phase II trial. Am J Transl Res. 2021 Aug 15;13(8):9015-9023. eCollection 2021.
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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.
Qun Zhao principal investigator
Hebei Medical University Fourth Hospital
Jun Wang principal investigator
Hebei Medical University Fourth 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, Capecitabine and Oxaliplatin in people with Gastroesophageal Junction Adenocarcinoma, run by Hebei 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 10 inclusion and 11 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 19 Feb 2020. 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 Qun Zhao (13930162111, Zhaoqun516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The pathological complete response rate(pCR) (time frame: within 3 weeks after surgery). 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 NCT03349866, 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 19 Feb 2020.