This study is a randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Study of SYS6010 vs Investigator's Choice Single-Agent Chemotherapy in Locally Advanced/Metastatic/Recurrent ESCC Patients with Failure of At Least One Line of Systemic Therapy
Voluntarily sign the Informed Consent Form (ICF);
Aged ≥18 years at the time of ICF signing, regardless of gender;
Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) with unresectable locally advanced disease, local recurrence, or distant metastasis;
Subjects with disease progression or intolerance after at least one line of systemic therapy.
A past pathological diagnosis of esophageal cancer with adenocarcinoma, adenosquamous carcinoma, or other pathological types.
Active central nervous system (CNS) metastasis and/or meningeal metastasis. Subjects with supratentorial and/or cerebellar (i.e., no midbrain, pons, or medulla oblongata) metastasis who achieve stable disease for at least 4 weeks prior to randomization after local therapy (imaging shows no new brain metastases or no enlargement of existing brain metastatic lesions, and all neurological symptoms are stable or return to normal), and who do not require glucocorticoid therapy or are receiving a daily prednisone dose of ≤10 mg or an equivalent dose of other glucocorticoids, are eligible for the study.
Receipt of oral chemotherapeutic agents or small-molecule targeted therapy agents within 2 weeks prior to randomization or within 5 half-lives of the drug (whichever is shorter);
Receipt of traditional Chinese medicine (TCM) or proprietary Chinese medicines with anti-tumor indications within 2 weeks prior to randomization;
Parallel
SYS6010
DrugSYS6010 IV
Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)
DrugInvestigator's choice of chemotherapy means the chemotherapy chosen by investigators/doctors to treat Locally Advanced/Metastatic/Recurrent ESCC, including Irinotecan hydrochloride（125 mg/m\^2 by IV on D1 and D8，3 weeks/cycle；or 150 \~180 mg/m\^2 by IV on D1，Q2W，4 weeks/cycle）， Paclitaxel（175 mg/m\^2 by IV on D1，3 weeks/cycle；or 80 mg/m\^2 by IV on D1/D8/D15/D22，4 weeks/cycle；or 80 mg/m\^2 by IV on D1/D8/D15，4 weeks/cycle）, or Docetaxel（75\~100 mg/m\^2 by IV on D1，3 weeks/cycle）
Progression Free Survival (PFS) Assessed by Blinded Independent Central Review(BICR) According to the RECIST 1.1 Criteria
PFS is defined as the time from the date of randomization to the first documentation of PD as assessed by investigator per RECIST v.1.1, or death due to any cause, whichever occurs earlier.
Overall Survival (OS)
Overall survival is defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the participant is known to be alive.
Objective Response Rate (ORR)
Objective response rate is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per RECIST v.1.1.
Duration of Response (DOR)
DOR is defined as the time from the date of the first confirmed objective response (CR or PR that is subsequently confirmed) to the date of the first documented disease progression (PD) per RECIST v1.1 or death from any cause, whichever occurs first.
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Clinical Benefit Rate（CBR）
CBR is defined as the percentage of participants who achieve remission (CR PR) after treatment and have at least 6 months of disease stabilization.
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