YL201 vs physician's choice chemotherapy in advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized trial conducted at multiple hospitals to compare YL201 with the physician's choice of chemotherapy in patients with unresectable locally advanced or metastatic ESCC after failure of first-line therapy. Participants are assigned to receive either YL201 or a standard chemotherapy regimen selected by their treating doctor, and the study will assess safety, pharmacokinetics, immune reactions, and potential biomarkers of response. Key eligibility requires adult patients with good performance status and measurable disease, who have progressed after one prior systemic therapy. The trial will collect tissue samples to explore predictors of response and monitor adverse events per CTCAE guidelines. Primary results will focus on whether YL201 improves outcomes compared with standard chemotherapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• 144
  Anqing, Anhui, China Recruiting
• 135
  Bengbu, Anhui, China Recruiting
• 133
  Hefei, Anhui, China Recruiting
• 143
  Hefei, Anhui, China Recruiting
• 129
  Beijing, Beijing Municipality, China Recruiting
• 161
  Beijing, Beijing Municipality, China Recruiting

+31 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Medilink Study Team
• Email: clinicaltrials@medilinkthera.com
• Phone: 051262858368

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• JS212 plus JS001 and 5‑FU for advanced esophageal squamous cell carcinoma

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• Testing a new antibody treatment for advanced squamous cell cancers

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.