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
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)
1 other identifier
interventional
440
1 country
81
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2026
Typical duration for phase_3
81 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
July 16, 2026
July 1, 2026
2.1 years
March 17, 2026
July 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Up to Approximately 36 Months
Secondary Outcomes (5)
Progression-Free Survival (PFS)
Up to Approximately 36 Months
Overall response rate (ORR)
Up to Approximately 36 Months
Disease control rate (DCR)
Up to Approximately 36 Months
Duration of Response (DOR)
Up to Approximately 36 Months
Adverse Event (AE)
Up to Approximately 36 Months
Study Arms (2)
YL201
EXPERIMENTALYL201 monotherapy
Control
ACTIVE COMPARATORInvestigator's choice of Chemotherapy
Interventions
YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).
Eligibility Criteria
You may qualify if:
- Age: ≥18 years;
- Voluntary participation in this study with signed informed consent and good compliance.
- ECOG PS score: 0-1;
- estimated life expectancy \>3 months;
- Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease
- Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression
- Adequate organ function.
- At least one measurable lesion
- Willing to provide biopsy or archived tumor tissue.
You may not qualify if:
- Other malignancies within 5 years prior to first dose or currently concurrent malignancies.
- Prior treatment-related adverse events not resolved to ≤Grade 1 per CTCAE v5.0, except for alopecia (any grade), hyperpigmentation (any grade), peripheral neuropathy (≤ Grade 2), and lymphopenia (≤ Grade 3).
- Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment
- Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0.
- Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out.
- History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded.
- Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Known allergy to any component of the investigational product; history of severe allergic reactions (e.g., anaphylactic shock); or known history of severe hypersensitivity reactions to other monoclonal antibodies or recombinant proteins, or previous severe infusion reactions.
- Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period.
- Any disease, medical condition, organ dysfunction, or social/psychological circumstance that, in the investigator's judgment, may interfere with the participant's ability to sign the informed consent form (ICF), compromise cooperation or compliance with study procedures, or affect the interpretation of study results. This includes, but is not limited to, psychiatric disorders, substance/alcohol abuse, or a history of drug abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 250117, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2026
First Posted
March 23, 2026
Study Start
March 24, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
July 16, 2026
Record last verified: 2026-07