Study of Anlotinib in Patients With Esophageal Squamous Cell Carcinoma (ALTER1102)

• Status: Completed
• Trial end date: 2018-07-23
• Target enrollment: 0
• Participant gender: All

Summary

To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Criteria

Inclusion Criteria:

• Histological documentation of esophageal squamous cell carcinoma；

• Advanced esophageal squamous cell carcinoma with distant metastasis(Stage IV),at least one measurable lesion (by RECIST1.1)

• Patients who at least have failed to a platinum-based chemotherapy treatment or chemotherapy containing paclitaxel.

Note: (1) Each line treatment refers to treatment duration at least one cycle using monotherapy or drug combination; (2)Adjuvant chemotherapy or neoadjuvant chemoradiation is permitted before the study (if disease recurred during adjuvant chemotherapy/neoadjuvant chemoradiation or recurred within 6 months after stopping treatment, adjuvant chemotherapy/neoadjuvant chemoradiation can be considered as first line systemic chemotherapy;

• 18-75 years,ECOG PS:0-2,Life expectancy of more than 3 months

• 4 weeks or more from the last cytotoxic therapy, radiation therapy or surgery

• Main organs function is normal

• Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped

• Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

• Patients whose primary lesion with active bleeding within 2 months

• Primary lesion not resected and has not shrinked after radiation therapy

• Patients who have been failure with anti-tumor angiogenesis drug treatment

• Patients with factors that could affect oral medication (such as dysphagia，chronic diarrhea, intestinal obstruction etc.)

• Brain metastases patients with symptoms or symptoms controlled < 3 months

• Patients with any severe and/or unable to control diseases，including：

1. Blood pressure unable to be controlled ideally(systolic pressure≥150 mmHg，diastolic pressure≥100 mmHg);

2. Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥480ms) and patients with Grade 1 or higher congestive heart failure (NYHA Classification);

3. Patients with active or unable to control serious infections;

4. Patients with cirrhosis, decompensated liver disease, or active hepatitis;

5. Patients with poorly controlled diabetes (fasting blood glucose(FBG)>10mmol/L)

6. Urine protein ≥ ++，and 24-hour urinary protein excretion>1.0 g confirmed

• Patients with non-healing wounds or fractures

• Patients with any CTC AE Grade 1 or higher bleeding events occurred in the lungs or any CTC AE Grade 2 or higher bleeding events occurred within 4 weeks prior to assignment;Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation

• Patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism

• Patients with drug abuse history and unable to get rid of or Patients with mental disorders

• Imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage

• Patients participated in other anticancer drug clinical trials within 4 weeks

• History of immunodeficiency

• Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment