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

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Esophageal Squamous Cell Carcinoma(ALTER1102)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649361
• Other study ID #: ALTN-11-II
• Status: Completed
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: July 23, 2018

Study information

• Verified date: June 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Placebo
Placebo p.o. qd

Locations

Country	Name	City	State
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Ruijin Hospital Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tianjin Medical University Cancer Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Cancer Hospital of Xinjiang Medical University	Wulumuqi	Xinjiang
China	The First Affiliated Hospital of Xian Jiaotong University	Xian	Shanxi
China	The First Affiliated Hospital of Xinxiang Medical College	Xinxiang	Henan
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress free survival (PFS)		From randomization,each 42 days up to PD or death(up to 24 months)
Secondary	Overall Survival (OS)		From randomization until death (up to 24 months)
Secondary	Objective Response Rate (ORR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)
Secondary	Disease Control Rate (DCR)		each 42 days up to intolerance the toxicity or PD (up to 24 months)