Apatinib in the Treatment of Recurrence or Metastasis of Esophageal Cancer

• Status: Recruiting
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

Summary

It was difficult to obtain clinical benefits through traditional chemotherapy and radiotherapy for the patients who have recurrence or metastasis tumor even though they have received first-line chemotherapy or combined radiotherapy before, but failed.The aim of this study was to evaluate the safety and efficacy of apatinib, an anti-angiogenesis drug, in the treatment of patients with advanced esophageal squamous cell carcinoma who had recurrence or metastasis after radical resection

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Chest Hospital
• Treatments: Apatinib

Criteria

Inclusion Criteria:

1. Age over 18;

2. ECOG score 0-2;

3. Postoperative pathology confirmed esophageal squamous cell carcinoma;

4. Have never received targeted therapy before;

5. Patients who had failed chemotherapy with platinum or paclitaxel regimens at least once in the past; Note: (1) At least one cycle of drug use, regardless of single or multiple drug combinations;(2) Neoadjuvant concurrent chemoradiotherapy, neoadjuvant chemotherapy or adjuvant chemotherapy are allowed;

6. According to RECIST version 1.1, there is at least one measurable lesion;

7. The estimated survival time is more than 3 months;

8. The main organs are functioning well, and the examination indicators meet the following requirements:

(1) Blood examination: Hemoglobin (>90 g/L) (no blood transfusion within 14 days);The neutrophil count (>1.5×109/L);Platelet count (> 80×109/L); (2)Biochemical examination:Total bilirubin<1.5×upper limit of normal (ULN);alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) are less than 2.5×ULN, ALT or AST are less than 5×ULN if liver metastasis occurred, and creatinine clearance is more than 50 ml/min (Cockcroft-Gault formula); 9.Sign the informed consent; 10.Good compliance, family members agreed to cooperate with survival follow-up;

Exclusion criteria

Subjects may not enter the trial with one of the following:

1. There were other malignant tumors at the same time, except cured skin basal cell carcinoma and cervical carcinoma in situ of cervix;

2. Pregnant or lactating women;

3. Participated in clinical trials of other drugs within one month;

4. Must be able to swallow tablets;

5. Any bleeding events with a severe grade of 3 or more in CTCAE 4.0 occurred within 4 weeks before screening;

6. Patients with central nervous system metastasis or a history of central nervous system metastasis before screening;

7. Patients with hypertension who can not be well controlled by a single anti-hypertensive drug (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg); those with a history of unstable angina pectoris; those newly diagnosed as angina pectoris within the first three months of screening or those with myocardial infarction within the first six months of screening; arrhythmia require long-term use of anti-arrhythmic drugs and cardiac insufficiency > Grade II (New York Heart Disease Association Grade) ;

8. Long-term nonunion of wounds or incomplete healing of fractures;

9. History of organ transplantation in the past;

10. Images show that the tumors have invaded important blood vessels or tumor was highly likely to invade important blood vessels during treatment and might cause fatal massive hemorrhage;

11. Patients who have bleeding tendency with abnormal blood coagulation (PT>16s, APTT>43s, TT>21s, Fbg<2g/L); patients treated with anticoagulant or vitamin K antagonists such as warfarin, heparin or its analogues, use a small dose of warfarin (1 mg orally once daily) or a small dose of aspirin (with a daily dose of no more than 100 mg) for prophylactic purposes under the premise of prothrombin time international normalized ratio (INR)≤1.5;

12. Arteriovenous thrombosis events occurred in one year ago, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by venous catheterization due to pre-chemotherapy,but healed) and pulmonary embolism;

13. Patients who have a history of psychotropic drug abuse and were unable to give up or have mental disorders;

14. Patients who have a history of immunodeficiency or other acquired or congenital immunodeficiency disorders or organ transplantation;

15. There were concomitant diseases that seriously endanger the safety of patients or affect the completion of the study according to the judgement of the researcher.