Clinical trial NCT03154983: The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer
Official title: The Clinical Research of Mesylate Apatinib Combined With Docetaxel and S-1 as the First-line Treatment of Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Metastatic Gastric Cancer
Keywords: Mesylate Apatinib
The First-line Treatment
Metastatic Gastric Cancer
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Hubei Cancer Hospital
name: Huangshi Central Hospital, China
name: The Central Hospital of Huanggang
name: Xianning Central Hospital
name: Taihe Hospital
name: The first hospital of Zaoyang
name: Hanchuan City people's Hospital
name: Yangxin People's Hospital
name: Tianmen People's Hospital
First posted: 2017-05-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Apatinib Mesylate Tablets combined with docetaxel and S-1 as the first-line treatment of metastatic gastric cancer.


Eligibility criteria: Inclusion Criteria:

1. Age: 18-70 years of age;
2. recurrent or metastatic adenocarcinoma of the stomach or gastroesophageal junction diagnosed by pathology (including histology or cytology);
3. 1 measurable lesions at least should be detected by CT/MRI examination in accordance with the RECIST(Response Evaluation Criteria In Solid Tumors）1.1;
4. had not received other anti VEGFR targeted therapy;
5. ECOG（Eastern Cooperative Oncology Group）PS（Performance Status）:0-2 scores;
6. the expected survival time is more than 3 months;
7. if patient had accepted the chemotherapy, the time from the last chemotherapy should be more than 6 months;
8. the damage caused by other treatments has been restored, and the subjects received radiotherapy or surgery over 4 weeks ago, and the wound has healed completely;
9. the main organ function is normal, which should meet the following criteria: (1) blood routine examination standards should be met: (no blood transfusion within 14 days) A. HB（hemoglobin） = 90g/L, B. ANC(absolute neutrophil count) = 1.5 \* 109/L, C. PLT（platelet） = 80 \* 109/L; (2) biochemical examination shall comply with the following criteria: A. BIL（bilirubin） \<1.25 normal upper limit (ULN), B. ALT（glutamic-pyruvic transaminase） and AST（glutamic-oxalacetic transaminase）\<2.5ULN（upper limit of normal）, if subjects have liver metastases, the ALT and AST \<5ULN（upper limit of normal）, C. Cr ≤ 1ULN, CCR（creatinine clearance rate） \> 50ml/min (Cockcroft-Gault formula);
10. women of childbearing age must have a pregnancy test in 7 days before entering the group (in serum), and the results were negative, and willing to use appropriate contraception during the study period and the last 8 weeks after giving drug test; men should have the surgical sterilization, or adopt the appropriate contraceptive methods during the test and the last 8 weeks after giving drug test;
11. participants is willing to participate in this study, sign the informed consent, have good compliance, cooperate with follow-up.

Exclusion Criteria:

1. Suffering from other malignant tumors previously or at the same time, with the exception of cured skin basal cell carcinoma and cervical carcinoma in situ;
2. Patients have used the paclitaxel class and / or S-1 as the adjuvant therapy in 2;
3. have been confirmed to be allergic to docetaxel, 5-fluorouracil, apatinib and / or its accessories;
4. the blood pressure of patients with hypertension cannot be reduced to the normal range by the antihypertensive drugs (systolic pressure \>140 mmHg, diastolic pressure \>90 mmHg);
5. patients are suffering from severe cardiovascular disease: the II level of myocardial ischemia or myocardial infarction, poor control of the arrhythmia (including QTc(corrected QT interval) prolongation of male \> 450 ms, of female \> 470ms ); and patients have III-IV grade of cardiac insufficiency, or left ventricular (LVEF) \< 50% shown by echocardiography according to the NYHA(New York Heart Association) standard;
6. patients are positive of urine protein (urine protein detection 2+ or above, or 24 hours urine protein quantitative \>1.0g);
7. have a variety of factors that affect oral drugs (such as difficulty in swallowing, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc.);
8. patients have a clear tendency with gastrointestinal bleeding, including the following situation: local active ulcerative lesions, and fecal occult blood (+ +); with melena and hematemesis history in 2 months; and patients with fecal occult blood (+) and unresected gastric primary tumor; patients with the risk of bleeding should take the gastroscopy test, if it is the gastric cancer, and researchers believe that may results in massive digestive tract hemorrhage;
9. coagulation dysfunction (INR(international normalized ratio)\>1.5, APTT(activated partial thromboplastin time)\>1.5 ULN), with bleeding tendency;
10. patients with a history of psychotropic substance abuse and unable to give up or have mental disorders;
11. Patients who participated in other clinical trials within 4 weeks;
12. have received the VEGFR inhibitors, such as sorafenib and sunitinib;
13. according to the researcher's judgment, there are other accompanying disease endangering the patient's safety or affect the patient to complete the study.
14. patients with central nervous system metastasis;
15. pregnant or lactating women;
16. the researchers consider those who were not suitable for inclusion.

Primary outcomes:
measure: progress-free survival time
timeFrame: 30 months
Secondary outcomes:
measure: Overall survival Time
timeFrame: 30 months
measure: Overall remission Rate
timeFrame: during 6 cycles of chemotherapy (each cycle is 28 days)
measure: adverse events
timeFrame: up to 28 weeks
measure: Quality of life
timeFrame: 30 months
measure: disease control rate
timeFrame: 30 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fuxiang Zhou, M.D.
role: STUDY_CHAIR
References: