Clinical trial NCT03986385: Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Gastroesophageal Junction
Official title: Prospective, Randomized, Controlled, Multicenter, Phase III Study of Apatinib Plus Concurrent Neoadjuvant Chemoradiotherapy for Siewert II ，III of Locally Advanced HER-2 Negative Adenocarcinoma at Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 gastroesophageal junction.


Eligibility criteria: Inclusion Criteria:

1. Adult patients (18 to 70 years old) at the time of voluntarily signing informed consent;
2. Histologically or cytologically confirmed adenocarcinoma. The her-2 negative was detected by immunohistochemistry or fluorescence in situ hybridization;
3. Conﬁrmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction and tumor long diameter ≤8 cm by gastroscopy;
4. Patients with Stage for Ⅲ by CT/MRI (According to the eighth edition of AJCC );
5. Patients with measurable lesions(measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1);
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
7. Life expectancy greater than or equal to 6 months;
8. Subject must meet all of the following criteria based on the laboratory tests within 14 days prior to the first dose of study treatment.

(1) Baseline blood indicators meet the following criteria:HB≥80g/L;ANC≥1.5×109/L;PLT≥90×109/L;WBC≥4.0×109/L and ≤15×109/L (2) Baseline biochemical indicators meet the following criteria: ALT and AST≤2.5ULN, but\<≤5ULN if the transferanse elevation is due to liver metastases; ALP≤2.5ULN;TBiL≤1.5ULN；Cr≤1.5ULN,Endogenous creatinine clearance rate ˃60 ml/min (Cockcroft-Gault formula);APTT≤1.5ULN,and INR or PT≤1.5ULN.

9.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; 10.Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Allergic to apatinib, capecitabine and oxaliplatin;
2. The cytological examination of the abdominal cavity washing fluid showed that the tumor shedding cells were positive;
3. 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;
4. A variety of factors influencing oral drugs (such as unable to swallow, nausea,vomiting,chronic diarrhea and intestinal obstruction, etc);
5. 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;
6. Coagulant function abnormality (INR \> 1.5 ULN, APTT \> 1.5 ULN), with bleeding tendency;
7. Pregnant or lactating women;
8. Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
9. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
10. Less than 4 weeks from the last clinical trial;
11. The researchers think inappropriate.

Primary outcomes:
measure: The pathological complete response rate(pCR)
timeFrame: [ Time Frame: within 3 weeks after surgery ]
measure: Disease-free survival(DFS)
timeFrame: [ Time Frame: 3 year ]
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: [ Time Frame: Preoperative ]
measure: Disease Control Rate（DCR）
timeFrame: [ Time Frame: Preoperative ]
measure: R0-resection rate
timeFrame: [ Time Frame: within 3 weeks after surgery ]
measure: Overall survival (OS)
timeFrame: [ Time Frame: 3years ]
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: QunZhao
state: Hebei
Study officials:
References: