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This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab | Experimental | Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w approximately 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab | Drug | Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate(ORR)by RECIST 1.1,the total proportion of patients with complete response(CR), partial response(PR) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | Time from treatment until disease progression or death | 2 years |
| Disease Control Rate (DCR) | the total proportion of patients with complete response(CR), partial response(PR)and stable disease(SD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fenghua wang, MD, PhD | Contact | 86-2087343795 | wangfeng@sysucc.org.cn | |
| miaozhen qiu | Contact | 86-2087343795 | qiumzh@sysucc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ruihua Xu, MD, PhD | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer center of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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|
| 2 years |
| Duration of Response(DoR) | Time from the achievement of a response to progression | 2 years |
| Overall survival(OS) | Time from treatment until death from any cause | 3 years |
| 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 |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000082082 | Immune Checkpoint Inhibitors |
| C000656314 | toripalimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000074322 | Antineoplastic Agents, Immunological |
| D000970 | Antineoplastic Agents |
| D045506 | Therapeutic Uses |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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