Advanced Esophageal Squamous Cell CarcinomaPhase 3NCT07487896
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 Phase 3 study testing YL201, Paclitaxel and Docetaxel in people with Advanced Esophageal Squamous Cell Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 81 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- YL201, Paclitaxel and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 81 sitesChina
- Study dates
- 24 Mar 2026to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Adequate organ function.
- At least one measurable lesion
- Willing to provide biopsy or archived tumor tissue.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
81 sites in 1 country. Contact the study team or a site near you to ask about taking part.
81 sites in 1 country
China81 sites, 81 recruiting
- Recruiting
144
Anqing, Anhui
study coordinator
- Recruiting
102
Anyang, Henan
study coordinator
- Recruiting
129
Beijing, Beijing Municipality
study coordinator
- Recruiting
161
Beijing, Beijing Municipality
study coordinator
- Recruiting
183
Beijing, Beijing Municipality
study coordinator
- Recruiting
135
Bengbu, Anhui
study coordinator
- Recruiting
125
Changchun, Jilin
study coordinator
- Recruiting
151
Changsha, Hunan
study coordinator
- Recruiting
182
Changsha, Hunan
study coordinator
- Recruiting
111
Chengdu, Sichuan
study coordinator
- Recruiting
116
Chengdu, Sichuan
study coordinator
- Recruiting
118
Chengdu, Sichuan
study coordinator
- Recruiting
119
Chongqing, Chongqing Municipality
study coordinator
- Recruiting
120
Chongqing, Chongqing Municipality
study coordinator
- Recruiting
184
Foshan, Guangzhou
study coordinator
- Not yet recruiting
110
Fuzhou, Fujian
study coordinator
- Recruiting
147
Fuzhou, Fujian
study coordinator
- Recruiting
149
Guangzhou, Guangdong
study coordinator
- Recruiting
154
Guangzhou, Guangdong
study coordinator
- Recruiting
158
Handan, Hebei
study coordinator
- Recruiting
176
Handan, Hebei
study coordinator
- Recruiting
108
Hangzhou, Zhejiang
study coordinator
- Recruiting
109
Hangzhou, Zhejiang
study coordinator
- Recruiting
174
Hangzhou, Zhejiang
study coordinator
- Recruiting
122
Harbin, Heilongjiang
study coordinator
- Recruiting
170
Harbin, Heilongjiang
study coordinator
- Recruiting
133
Hefei, Anhui
study coordinator
- Recruiting
143
Hefei, Anhui
study coordinator
- Recruiting
165
Huai'an, Jiangsu
study coordinator
- Recruiting
128
Jilin City, Jilin
study coordinator
- Recruiting
101
Jinan, Shandong, 250117
study coordinator
- Recruiting
139
Jinan, Shandong
study coordinator
- Recruiting
178
Jinan, Shandong
study coordinator
- Recruiting
115
Kunming, Yunnan
study coordinator
- Recruiting
180
Langfang, Hebei
study coordinator
- Recruiting
175
Lanzhou, Gansu
study coordinator
- Recruiting
138
Linyi, Shandong
study coordinator
- Recruiting
141
Linyi, Shandong
study coordinator
- Recruiting
105
Luoyang, Henan
study coordinator
- Recruiting
168
Meizhou, Guangzhou
study coordinator
- Recruiting
153
Mianyang, Sichuan
study coordinator
- Recruiting
117
Nanchang, Jiangxi
study coordinator
- Recruiting
121
Nanchang, Jiangxi
study coordinator
- Recruiting
152
Nanchong, Sichuan
study coordinator
- Recruiting
107
Nanjing, Jiangsu
study coordinator
- Recruiting
112
Nanning, Guangxi
study coordinator
- Recruiting
150
Nanning, Guangxi
study coordinator
- Recruiting
177
Nantong, Jiangsu
study coordinator
- Recruiting
132
Nanyang, Henan
study coordinator
- Recruiting
137
Qingdao, Shandong
study coordinator
- Recruiting
106
Shanghai, Shanghai Municipality
study coordinator
- Recruiting
134
Shanghai, Shanghai Municipality
study coordinator
- Recruiting
172
Shanghai, Shanghai Municipality
study coordinator
- Recruiting
173
Shanghai, Shanghai Municipality
study coordinator
- Recruiting
169
Shantou, Guangzhou
study coordinator
- Recruiting
126
Shenyang, Niaoning
study coordinator
- Recruiting
157
Shenyang, Niaoning
study coordinator
- Recruiting
160
Shenyang, Niaoning
study coordinator
- Recruiting
156
Shijiazhuang, Hebei
study coordinator
- Recruiting
159
Shijiazhuang, Hebei
study coordinator
- Recruiting
146
Suining, Sichuan
study coordinator
- Recruiting
140
Suzhou, Jiangsu
study coordinator
- Recruiting
167
Tai’an, Shandong
study coordinator
- Recruiting
123
Taiyuan, Shanxi
study coordinator
- Recruiting
171
Taizhou, Jiangsu
study coordinator
- Recruiting
166
Tengzhou, Shandong
study coordinator
- Recruiting
124
Tianjin, Tianjin Municipality
study coordinator
- Recruiting
130
Ürümqi, Xinjiang
study coordinator
- Recruiting
179
Wenzhou, Zhejiang
study coordinator
- Recruiting
113
Wuhan, Hubei
study coordinator
- Recruiting
114
Wuhan, Hubei
study coordinator
- Recruiting
148
Wuhan, Hubei
study coordinator
- Recruiting
127
Xi’an, Shanxi
study coordinator
- Recruiting
162
Xi’an, Shanxi
study coordinator
- Recruiting
145
Xiamen, Fujian
study coordinator
- Recruiting
136
Xuzhou, Jiangsu
study coordinator
- Recruiting
155
Yichang, Hubei
study coordinator
- Recruiting
163
Yinchuan, Ningxia
study coordinator
- Recruiting
103
Zhengzhou, Henan
study coordinator
- Recruiting
104
Zhengzhou, Henan
study coordinator
- Recruiting
142
Zhengzhou, Henan
study coordinator
About this study
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)
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.
- Being tested
- YL201, Paclitaxel, Docetaxel, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YL201Drug
YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
PaclitaxelDrug
175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
DocetaxelDrug
75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W).
IrinotecanDrug
125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| YL201 | Experimental | YL201 monotherapy Receives: Drug: YL201 |
| Control | Active comparator | Investigator's choice of Chemotherapy Receives: Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from randomization to the event of death from any cause.
Measured: Up to Approximately 36 Months
Secondary outcomes (5)
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
Measured: Up to Approximately 36 Months
Overall response rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of confirmed Complete response (CR) or confirmed partial response (PR) as determined by investigator based on RECIST version 1.1.
Measured: Up to Approximately 36 Months
Disease control rate (DCR)
DCR is defined as the proportion of participants with complete response (CR), partial response (PR), or disease stabilization (SD) as determined by the investigator according to RECIST 1.1.
Measured: Up to Approximately 36 Months
Duration of Response (DOR)
DOR is defined as the time interval from the date of first documentation of objective response (CR or PR) to date of the first documentation of disease progression as determined by the investigator according to RECIST v1.1, or death due to any cause, whichever occurs first.
Measured: Up to Approximately 36 Months
Adverse Event (AE)
The incidence and severity of adverse events, with severity graded according to the NCI CTCAE v5.0 scale.
Measured: Up to Approximately 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start24 Mar 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by MediLink Therapeutics (Suzhou) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487896
- Sponsor's protocol ID
- YL201-CN-303-01
- Status last verified
- Jul 2026
- First submitted
- 17 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07487896
- Acronym / sponsor ID
- YL201-CN-303-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YL201 | Experimental | Drug: YL201YL201 monotherapy |
| Control | Active comparator | Drug: Paclitaxel, Drug: Docetaxel, Drug: IrinotecanInvestigator's choice of Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YL201YL201, a B7H3 targeting ADC，administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). | Drug | YL201 |
| Paclitaxel175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). | Drug | Control |
| Docetaxel75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). | Drug | Control |
| Irinotecan125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W). | Drug | Control |
Primary outcome
Overall Survival (OS)
Time frame: Up to Approximately 36 Months
OS is defined as the time from randomization to the event of death from any cause.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to Approximately 36 Months
Overall response rate (ORR)
Time frame: Up to Approximately 36 Months
Disease control rate (DCR)
Time frame: Up to Approximately 36 Months
Duration of Response (DOR)
Time frame: Up to Approximately 36 Months
Adverse Event (AE)
Time frame: Up to Approximately 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
81 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YL201, Paclitaxel and Docetaxel in people with Advanced Esophageal Squamous Cell Carcinoma, run by MediLink Therapeutics (Suzhou) Co., Ltd. at 81 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medilink Study Team (051262858368, clinicaltrials@medilinkthera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to Approximately 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.