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A Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy
Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd.
Summary
This is a large clinical study carried out at multiple hospitals. Participants will be randomly assigned to one of two groups: one group will receive a new medicine called YL201, and the other group will receive standard chemotherapy chosen by the doctor. The purpose of the study is to see whether YL201 works better and is safer for people with locally advanced or metastatic esophageal squamous cell carcinoma whose first-line treatment has stopped working. The study will also look at how YL201 is processed in the body (Pharmacokinetics), whether it triggers any immune reactions, and whether certain biological markers can help predict how well it works.
Official title: A Randomized, Controlled, Multicenter Phase III Study of YL201 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-Line Therapy (TAISHAN-303)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2026-03-24
Completion Date
2028-12-31
Last Updated
2026-07-16
Healthy Volunteers
No
Interventions
YL201
YL201, a B7H3 targeting ADC,administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Paclitaxel
175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Docetaxel
75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Irinotecan
125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Locations (81)
144
Anqing, Anhui, China
135
Bengbu, Anhui, China
133
Hefei, Anhui, China
143
Hefei, Anhui, China
129
Beijing, Beijing Municipality, China
161
Beijing, Beijing Municipality, China
183
Beijing, Beijing Municipality, China
119
Chongqing, Chongqing Municipality, China
120
Chongqing, Chongqing Municipality, China
110
Fuzhou, Fujian, China
147
Fuzhou, Fujian, China
145
Xiamen, Fujian, China
175
Lanzhou, Gansu, China
149
Guangzhou, Guangdong, China
154
Guangzhou, Guangdong, China
112
Nanning, Guangxi, China
150
Nanning, Guangxi, China
184
Foshan, Guangzhou, China
168
Meizhou, Guangzhou, China
169
Shantou, Guangzhou, China
158
Handan, Hebei, China
176
Handan, Hebei, China
180
Langfang, Hebei, China
156
Shijiazhuang, Hebei, China
159
Shijiazhuang, Hebei, China
122
Harbin, Heilongjiang, China
170
Harbin, Heilongjiang, China
102
Anyang, Henan, China
105
Luoyang, Henan, China
132
Nanyang, Henan, China
103
Zhengzhou, Henan, China
104
Zhengzhou, Henan, China
142
Zhengzhou, Henan, China
113
Wuhan, Hubei, China
114
Wuhan, Hubei, China
148
Wuhan, Hubei, China
155
Yichang, Hubei, China
151
Changsha, Hunan, China
182
Changsha, Hunan, China
165
Huai'an, Jiangsu, China
107
Nanjing, Jiangsu, China
177
Nantong, Jiangsu, China
140
Suzhou, Jiangsu, China
171
Taizhou, Jiangsu, China
136
Xuzhou, Jiangsu, China
117
Nanchang, Jiangxi, China
121
Nanchang, Jiangxi, China
125
Changchun, Jilin, China
128
Jilin City, Jilin, China
126
Shenyang, Niaoning, China
157
Shenyang, Niaoning, China
160
Shenyang, Niaoning, China
163
Yinchuan, Ningxia, China
101
Jinan, Shandong, China
139
Jinan, Shandong, China
178
Jinan, Shandong, China
138
Linyi, Shandong, China
141
Linyi, Shandong, China
137
Qingdao, Shandong, China
167
Tai’an, Shandong, China
166
Tengzhou, Shandong, China
106
Shanghai, Shanghai Municipality, China
134
Shanghai, Shanghai Municipality, China
172
Shanghai, Shanghai Municipality, China
173
Shanghai, Shanghai Municipality, China
123
Taiyuan, Shanxi, China
127
Xi’an, Shanxi, China
162
Xi’an, Shanxi, China
111
Chengdu, Sichuan, China
116
Chengdu, Sichuan, China
118
Chengdu, Sichuan, China
153
Mianyang, Sichuan, China
152
Nanchong, Sichuan, China
146
Suining, Sichuan, China
124
Tianjin, Tianjin Municipality, China
130
Ürümqi, Xinjiang, China
115
Kunming, Yunnan, China
108
Hangzhou, Zhejiang, China
109
Hangzhou, Zhejiang, China
174
Hangzhou, Zhejiang, China
179
Wenzhou, Zhejiang, China