| Eligibility |
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.
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