Clinical Trial to Compare Apatinib Plus Irinotecan Versus Single Irinotecan as Second-line Treatment in AGC or EGJA

This is an interventional treatment trial for Advanced Gastric Cancer Adenocarcinoma of Esophagogastric Junction Read More

Inclusion Criteria:

1. Age：18~70years;
2. Subjects with Histologically or cytologically confirmed advanced gastric cancer or adenocarcinoma of esophagogastric junction ；
3. Subjects must have received no more than one lines treatment before participating,and have received no irinotecan or antiangiogenic（including apatinib）treatment previously; Note：(1) Time of first-line treatment for subjects with advanced tumour must more than 1 cycles;(2) Adjuvant / neoadjuvant therapy was allowed; adjuvant / neoadjuvant therapy will be considered as a first-line treatment if disease recurrence during treatment or after less than 24 weeks.
4. subjects with at least one measurable lesion as defined by RECIST (version 1.1);Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1；
6. Survival expectation≥ 3 months;
7. The interval of subjects had received cytotoxic drugs, radiotherapy or surgery must more than 4 weeks(besides nitroso or mitomycin must more than 6 weeks), and the wound has healed before participating;
8. No serious concomitant diseases(including heart,lung,liver jaundice or gastrointestinal obstruction and so on );

9. Adequate organ functions defined as indicated below： （1）Adequate bone marrow function, defined as: (no blood transfusion within 14 days)

   1. Hemoglobin (Hb)≥80g/L，
   2. White blood count (WBC)≥3.5×109/L
   3. Absolute neutrophil count (ANC)≥1.5×109/L，
   4. Platelet count (PLT)≥75×109/L； （2）Adequate liver function, defined as:
   1. Bilirubin ≤1.5×the upper limit of normal (ULN)
   2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) ≤3.0×(ULN), Glutamyl transpeptidase(GGT)≤2.5×(ULN), (When liver metastases, ALT or AST and GPT <5.0×(ULN)).
   3. serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula)
10. Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative, Females of childbearing potential must agree to use a highly effective method of contraception throughout the entire study period and for 8 weeks after study drug discontinuation. Male subjects must have had a successful vasectomy or they and their female partners must meet the criteria above (i.e.not of childbearing potential or practicing highly effective contraception throughout the study period and for 8 weeks after study drug discontinuation).
11. Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

1. Females are lactating or pregnant at Screening or Baseline
2. Subjects with other active malignancy (except for definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix)
3. Subjects with symptomatic brain metastases；
4. Subjects with uncontrolled blood pressure with medication (140/90 mmHg),
5. Subjects with coronary heart disease (CHD) above grade I, arrhythmia (including Prolongation of QTc interval : Male subjects > 450 ms, Females> 470 ms) or cardiac dysfunction;.
6. Subjects with gastrointestinal bleeding tendency,including the following: current of local active ulcerative lesions with fstool OB (+ +); history of melena or hematemesis within past 2 months ; current of fstool OB (+) with gastric primary tumor without surgical , investigator considerd ulcerative stomach cancer is associated with risks of gastrointestinal bleeding.
7. Subjects with bleeding tendency ，defined as abnormal coagulation (INR>1.5×(ULN),APTT>1.5 ×(ULN));
8. Subjects with previous history of cardiovascular and cerebrovascular diseases ,those receiving thrombolytics or anticoagulants were excluded
9. Subjects with urine protein positive (defined as urine protein detection 2+ or above, or urine protein ≥ 1 g/24 hours );
10. Subjects with a variety of factors that affect oral medications (such as inability to swallow, persistent nausea and vomiting, chronic diarrhea and intestinal obstruction, and so on.);
11. Subject with any other condition that in the opinion of the investigator would preclude his/her participation in a clinical study.