A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib

Randomized, Open, Positive Drug Control, Multicenter Clinical Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Squamous Cell Carcinoma With Chemotherapy in Patients Treated With Apatinib Mesylate

A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate

This is a randomized, open-label, multi-center, phase II clinical trial initiated by a investigator to observe and evaluate the efficacy of apatinib in the treatment of patients with failed first-line treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.

Inclusion Criteria:

• Pathological/histological diagnosis of esophageal squamous cell carcinoma; and at least one measurable lesion according to RECIST criteria (version 1.1);

• Patients who have undergone radical resection of esophageal cancer and who have failed after first-line systemic chemotherapy (which may include platinum, taxane or fluorouracil) after recurrence (recurrence of postoperative adjuvant chemotherapy within 6 months) Considered as first-line treatment, and the same progress in the field of radiation can be seen as recurrence;

• Age: 18-75 years old; both men and women;

• ECOG PS Rating: 0-1 points;

• Estimated survival period ≥ 3 months;

• ≥ 4 weeks from the last cytotoxic drug;

• The main organs function normally, that is, meet the following criteria:

  • Blood routine examination:

    • HB≥90 g/L; (no blood transfusion within 14 days)
    • ANC ≥ 1.5 × 109 / L;
    • PLT ≥ 80 × 109 / L;

  • Biochemical examinations must meet the following criteria:

    • ALT and AST < 2.5 ULN; if there is liver metastasis, ALT and AST < 5 ULN;
    • TBIL ≤ 1.5ULN;
    • Plasma Cr≤1.5ULN or creatinine clearance (CCr)≥60ml/min

• Subjects volunteered to participate in the study, signed informed consent, and were well-adhered to follow-up.

• Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months of the end of the study; negative serum or urine pregnancy tests within seven days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.

Exclusion Criteria:

• Those who have used anti-tumor angiogenesis drugs to treat failure;

• Patients with residual esophagus, residual stomach or anastomotic recurrence;

• Unable to swallow, chronic diarrhea and intestinal obstruction, which obviously affect the taking and absorption of drugs;

• Patients with brain metastases with symptoms or symptoms controlled for less than 3 months;

• Long-term unhealed wounds and fractures;

• Have clear gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood above ++), history of gastrointestinal bleeding within 6 months; coagulation abnormalities (PT>16 s, APTT>43 s, TT>21 s, Fbg< 2 g/L), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;

• Overactive/venous thrombosis occurred within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism;

• Imaging shows that the tumor has invaded the important perivascular circumference or that the patient is likely to invade the important blood vessels during the follow-up study and cause fatal bleeding.

• Persons with a history of psychotropic substance abuse who are unable to resolve or have a mental disorder;

• Participated in other clinical trials of anti-tumor drugs within four weeks;

• Have a history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation;

• According to the investigator's judgment, there are serious concomitant illnesses that compromise the safety of the patient or affect the patient's completion of the study.

• Patients with any severe and/or uncontrolled diseases, including:

  • Blood pressure control is unreasonable (retraction pressure >150mmHg, diastolic pressure >100mmHg) Patients: I have myocardial ischemia or myocardial infarction above grade I, arrhythmia (including QT interval >440ms) and grade I cardiac insufficiency;
  • Active or uncontrolled serious infections;
  • Liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis;
  • Poor diabetes control (fasting blood glucose FBG>10mmol/L);
  • Urine routine indicates urinary protein >++, and confirmed 24-hour urine protein quantitation >1.0g.

• The investigator believes that it is not suitable for inclusion.