Status:
WITHDRAWN
A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Esophageal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A study of second-line treatment of postoperative recurrence and metastasis of esophageal squamous cell carcinoma after chemotherapy with apatinib mesylate
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03787251
Start Date
January 1 2019
End Date
December 31 2021
Last Update
April 19 2022
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