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To compare the effects and safety of Anlotinib with placebo in patients with esophageal squamous cell carcinoma(ESCC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Placebo | Placebo Comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib p.o. qd |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | From randomization,each 42 days up to PD or death(up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) | |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) | |
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Inclusion Criteria:
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;
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33586360 | Derived | 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. |
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| Drug |
Placebo p.o. qd |
|
| Disease Control Rate (DCR) |
| each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| 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 |
| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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