Gastric cancer
Conditions
Interventions
case series:Apatinib combined with albumin-bound paclitaxel
Sponsors
The First Affiliated Hospital of Suzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient aged 18 to 75 years, male or female; 2. Advanced gastric adenocarcinoma (including gastroesophageal junction adenocarcinoma) confirmed by pathology, with extravasational measurable lesions (spiral CT scan >= 10mm, meeting RECIST 1.1 criteria); 3. The ECOG score is 0-1 points; 4. Patients with advanced gastric cancer who failed first-line chemotherapy (definition of treatment failure: intolerance of toxic side effects, disease progression during treatment or recurrence after treatment); previous systemic chemotherapy for gastric cancer and progress, the program should Contains fluorouracil (eg 5-FU, capecitabine or tegafur capsules) and/or cisplatin/oxaliplatin; or has received adjuvant chemotherapy, but develops disease within 6 months of treatment or Subjects with recurrence can be included in the study. If the patient has previously used albumin-bound taxanes, they cannot be enrolled. Note: (1) Treatment of each line of advanced disease includes one or more drugs with a dose of >= 1 cycle or longer. (2) Advance/adjuvant therapy is allowed in the early stage. Adjuvant/neoadjuvant therapy is considered a first-line systemic chemotherapy for advanced disease if recurrence occurs during or after 24 hours of adjuvant/neoadjuvant therapy. (3) Allowing pre-treatment is chemotherapy combined with targeted drugs 5. Estimated survival time >= 3 months; 6. Subjects received damage from other treatments, including nitroso or mitomycin interval >= 6 weeks; other cytotoxic drugs, radiation or surgery >= 4 weeks, and the wound has completely healed; 7. The heart function is good before enrollment. There is no myocardial infarction within half a year. Hypertension and other coronary heart disease are currently within the controllable range. The electrocardiogram is basically normal in the first 4 weeks after enrollment, and there is no clinically obvious heart disease. 8. The main organs function normally and meet the following requirements: (1) Blood routine examination, need to meet: (no blood transfusion within 14 days) a. HGB >= 90g / L; b. ANC >= 1.5 x 10^9 / L; c. PLT >= 100 x 10^9/L (2) Biochemical examinations must meet the following criteria: a. BIL = 50ml/min (Cockcroft-Gault formula); 9. There are no other uncontrollable benign diseases such as lungs, liver, kidneys, infections, etc. before enrollment; 10. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative, and are willing to use appropriate methods of contraception during the trial and 8 weeks after the last administration of the test drug. For men, surgery should be sterilized, or consent should be used during the trial and 8 weeks after the last administration of the test drug. 11. Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.
Exclusion criteria
Exclusion criteria: 1. Except for other malignant tumors in the past or at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ; pregnant or lactating women; 2. Patients with hypertension and antihypertensive medication can not be reduced to the normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg); 3. Previously suffered from severe cardiovascular disease: myocardial ischemia or myocardial infarction with grade II or higher, poorly controlled arrhythmias (including men with QTc interval >= 450 ms, women >= 470 ms); according to NYHA criteria, grades III to IV Cardiac dysfunction, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) 1.0g); 5. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 6. Patients with clear gastrointestinal bleeding concerns. Including the following conditions: local active ulcer lesions, and fecal occult blood (++) can not be included; 2 months have a history of hoarseness, hematemesis can not be included; for fecal occult blood (+) and the original tumor of the stomach is not For surgical resection, gastroscopy is required, such as ulcerative gastric cancer, and the investigator believes that gastrointestinal bleeding may not be included. 7. With central nervous system metastasis; supine B-ultrasound showing more than 3cm, with clinical symptoms, ascites requiring clinical treatment intervention; 8. Have received VEGFR inhibitors, such as sorafenib, sunitinib, etc.; 9. Exclude patients with known HER2 positive ( or HER2 borderline results , FISH confirmed positive); patients with HER2 negative positive unknown can be enrolled; 10. Long-term use of antiplatelet drugs such as aspirin and clopidogrel, or anticoagulant drugs such as warfarin; abnormal coagulation function (PT>16 s, APTT>43 s, TT>21 s, Fbg< 2 g/L), who have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy; the investigator believes that the risk of bleeding may occur; 11. Participated in other drug clinical trials within four weeks; 12. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder; 13. According to the investigator's judgment, there are serious concomitant diseases that endanger the safety of the patient or affect the patient's completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survial; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactJing Xie
The First Affiliated Hospital of Suzhou University
Outcome results
None listed