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Compares treatment options for Advanced Esophageal Squamous Cell Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT07487896
What this study is testing
What is YL201?
YL201 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced esophageal squamous cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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)...
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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)...
The study team makes the final eligibility decision.
Where it's taking place
- Anqing, Anhui, China
- Bengbu, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Xiamen, Fujian, China
- Lanzhou, Gansu, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Foshan, Guangzhou, China
- Meizhou, Guangzhou, China
- Shantou, Guangzhou, China
- Handan, Hebei, China
- Langfang, Hebei, China
- Shijiazhuang, Hebei, China
- Harbin, Heilongjiang, China
- Anyang, Henan, China
- Luoyang, Henan, China
- Nanyang, Henan, China
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anqing, Anhui, China; Bengbu, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.