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

CTTQ

Status and phase

Completed

Phase 2

Conditions

Esophageal Squamous Cell Carcinoma

Treatments

Drug: Placebo

Drug: Anlotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02649361

ALTN-11-II

Details and patient eligibility

About

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

Enrollment

164 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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