New drug YL201 takes on tough esophageal cancer

NCT ID NCT07487896

Disease control Sponsor: MediLink Therapeutics (Suzhou) Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 3 times

Summary

This large Phase 3 trial tests a new drug called YL201 against standard chemotherapy in 440 people with advanced esophageal cancer that has worsened after initial treatment. YL201 is a targeted therapy designed to deliver chemo directly to cancer cells. The study aims to see if it helps people live longer and with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: YL201 (a targeted drug that delivers chemotherapy to cancer cells)
What this could lead to: If it works, this could offer a new treatment option for people with advanced esophageal cancer when standard therapy stops working.
What could go wrong: This is an early-stage Phase 3 trial, so results are not yet known. The drug may not work better than current chemo and could have side effects like infusion reactions or organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: ≥18 years; 2. Voluntary participation in this study with signed informed consent and good compliance. 3. ECOG PS score: 0-1; 4. estimated life expectancy \>3 months; 5. Histologically or cytologically confirmed ESCC with unresectable locally advanced or metastatic disease 6. Previously received one line of systemic standard therapy for unresectable locally advanced or metastatic ESCC and experienced disease progression 7. Adequate organ function. 8. At least one measurable lesion 9. Willing to provide biopsy or archived tumor tissue. Exclusion Criteria: 1. Other malignancies within 5 years prior to first dose or currently concurrent malignancies. 2. 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). 3. Major surgery, significant traumatic injury within 4 weeks prior to first dose, or anticipated need for major surgery during study treatment 4. Any arterial thromboembolic event within 6 months prior to randomization, or venous thromboembolic events of Grade ≥ 3 according to NCI CTCAE version 5.0. 5. Known active tuberculosis (TB). Participants suspected of having active TB must undergo clinical evaluation to rule it out. 6. History of immunodeficiency or positive test for human immunodeficiency virus (HIV) antibodies. Participants with known active syphilis infection are also excluded. 7. Current active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). 8. 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. 9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study period. 10. 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.

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Conditions

The condition(s) this trial relates to.

esophageal squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced esophageal squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

81 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Study contacts

Contact

Email: •••••@•••••

Locations

101
RECRUITING

Jinan, Shandong, 250117, China
102
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Anyang, Henan, China
103
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Zhengzhou, Henan, China
104
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Zhengzhou, Henan, China
105
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Luoyang, Henan, China
106
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Shanghai, Shanghai Municipality, China
107
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Nanjing, Jiangsu, China
108
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Hangzhou, Zhejiang, China
109
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Hangzhou, Zhejiang, China
110
NOT_YET_RECRUITING

Fuzhou, Fujian, China
111
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Chengdu, Sichuan, China
112
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Nanning, Guangxi, China
113
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Wuhan, Hubei, China
114
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Wuhan, Hubei, China
115
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Kunming, Yunnan, China
116
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Chengdu, Sichuan, China
117
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Nanchang, Jiangxi, China
118
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Chengdu, Sichuan, China
119
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Chongqing, Chongqing Municipality, China
120
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Chongqing, Chongqing Municipality, China
121
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Nanchang, Jiangxi, China
122
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Harbin, Heilongjiang, China
123
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Taiyuan, Shanxi, China
124
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Tianjin, Tianjin Municipality, China
125
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Changchun, Jilin, China
126
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Shenyang, Niaoning, China
127
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Xi’an, Shanxi, China
128
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Jilin City, Jilin, China
129
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Beijing, Beijing Municipality, China
130
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Ürümqi, Xinjiang, China
132
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Nanyang, Henan, China
133
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Hefei, Anhui, China
134
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Shanghai, Shanghai Municipality, China
135
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Bengbu, Anhui, China
136
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Xuzhou, Jiangsu, China
137
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Qingdao, Shandong, China
138
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Linyi, Shandong, China
139
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Jinan, Shandong, China
140
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Suzhou, Jiangsu, China
141
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Linyi, Shandong, China
142
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Zhengzhou, Henan, China
143
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Hefei, Anhui, China
144
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Anqing, Anhui, China
145
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Xiamen, Fujian, China
146
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Suining, Sichuan, China
147
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Fuzhou, Fujian, China
148
RECRUITING

Wuhan, Hubei, China
149
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Guangzhou, Guangdong, China
150
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Nanning, Guangxi, China
151
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Changsha, Hunan, China
152
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Nanchong, Sichuan, China
153
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Mianyang, Sichuan, China
154
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Guangzhou, Guangdong, China
155
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Yichang, Hubei, China
156
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Shijiazhuang, Hebei, China
157
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Shenyang, Niaoning, China
158
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Handan, Hebei, China
159
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Shijiazhuang, Hebei, China
160
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Shenyang, Niaoning, China
161
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Beijing, Beijing Municipality, China
162
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Xi’an, Shanxi, China
163
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Yinchuan, Ningxia, China
165
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Huai'an, Jiangsu, China
166
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Tengzhou, Shandong, China
167
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Tai’an, Shandong, China
168
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Meizhou, Guangzhou, China
169
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Shantou, Guangzhou, China
170
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Harbin, Heilongjiang, China
171
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Taizhou, Jiangsu, China
172
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Shanghai, Shanghai Municipality, China
173
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Shanghai, Shanghai Municipality, China
174
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Hangzhou, Zhejiang, China
175
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Lanzhou, Gansu, China
176
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Handan, Hebei, China
177
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Nantong, Jiangsu, China
178
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Jinan, Shandong, China
179
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Wenzhou, Zhejiang, China
180
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Langfang, Hebei, China
182
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Changsha, Hunan, China
183
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Beijing, Beijing Municipality, China
184
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Foshan, Guangzhou, China

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