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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YL201 | Experimental | YL201 monotherapy |
|
| Control | Active Comparator | Investigator's choice of Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YL201 | Drug | YL201, a B7H3 targeting ADC,administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to the event of death from any cause. | Up to Approximately 36 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to Approximately 36 Months |
| Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medilink Study Team | Contact | 051262858368 | clinicaltrials@medilinkthera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 101 | Jinan | Shandong | 250117 | China |
|
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| Paclitaxel | Drug | 175 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). |
|
| Docetaxel | Drug | 75 mg/m², administered on Day 1 of each cycle, intravenous infusion, every 3 weeks (Q3W). |
|
| Irinotecan | Drug | 125 mg/m², administered on Days 1 and 8 of each cycle, intravenous infusion, every 3 weeks (Q3W). |
|
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. |
| 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. | 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. | 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. | Up to Approximately 36 Months |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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