Status:
UNKNOWN
A Prospective Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
Lead Sponsor:
Hebei Medical University
Conditions:
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03349866
Start Date
November 30 2017
End Date
November 30 2020
Last Update
February 19 2020
Active Locations (1)
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1
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China