Clinical trial NCT03787251: A Study of Second-line Treatment of Postoperative Recurrence and Metastasis of Esophageal Cancer Treated With Apatinib
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Esophageal Neoplasms
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 treatment after recurrence and metastasis of esophageal squamous cell carcinoma. Effectiveness and security.

Eligibility criteria: 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.

Primary outcomes:
measure: PFS
timeFrame: One year from admission
Secondary outcomes:
measure: OS
timeFrame: One year from admission
measure: DCR
timeFrame: One year from admission
measure: ORR
timeFrame: One year from admission
Other outcomes:
Locations:
Study officials:
References: