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RECRUITING
NCT07487896
PHASE3

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.

View on ClinicalTrials.gov

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

DRUG

YL201

YL201, a B7H3 targeting ADC,administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

DRUG

Paclitaxel

175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

DRUG

Docetaxel

75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).

DRUG

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