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

NCT ID: NCT02649361

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-07-23

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Anlotinib

Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: EXPERIMENTAL

Anlotinib

Intervention Type: DRUG

Anlotinib p.o. qd

Placebo

Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo p.o. qd

Interventions

Anlotinib

Anlotinib p.o. qd

Intervention Type: DRUG

Placebo

Placebo p.o. qd

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Harbin medical university affiliated tumor hospital

Harbin, Heilongjiang, 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, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Shandong Cancer Hospital

Jinan, Shandong, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xian Jiaotong University

Xian, Shanxi, China

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Countries

China

References

Huang J, Xiao J, Fang W, Lu P, Fan Q, Shu Y, Feng J, Zhang S, Ba Y, Zhao Y, Liu Y, Bai C, Bai Y, Tang Y, Song Y, He J. Anlotinib for previously treated advanced or metastatic esophageal squamous cell carcinoma: A double-blind randomized phase 2 trial. Cancer Med. 2021 Mar;10(5):1681-1689. doi: 10.1002/cam4.3771. Epub 2021 Feb 14.

Reference Type: DERIVED

PMID: 33586360 (View on PubMed)

Other Identifiers

ALTN-11-II

Identifier Type: -

Identifier Source: org_study_id