Not Yet RecruitingPhase 3

SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma

436 participantsStarted 2026-03-18

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. At least one evaluable lesion meeting the criteria of RECIST 1.1;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
✓. Expected survival≥3 months;
✓. Major organ functions meeting the prespecified criteria within 3 days prior to randomization

Exclusion criteria

✕. 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 any anti-tumor therapy (including but not limited to chemotherapy, immunotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks prior to randomization, with the exception of the following:
✕. 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;
✕. Receipt of local palliative radiotherapy for the purpose of relieving bone metastasis pain within 2 weeks prior to randomization;
✕. Receipt of major surgical treatment (excluding needle biopsy), participation in other clinical trials with study drug administration, or vaccination with live-attenuated vaccines within 4 weeks prior to randomization, or anticipated need for live-attenuated vaccine vaccination during the study period.
✕. Known hypersensitivity to any component of SYS6010, or to humanized monoclonal antibody products; hypersensitivity or contraindication to irinotecan, paclitaxel, or docetaxel.

What they're measuring

Progression Free Survival (PFS) Assessed by Blinded Independent Central Review(BICR) According to the RECIST 1.1 Criteria

Timeframe: Up to 2 years

Overall Survival (OS)

Timeframe: Up to 2 years

Trial details

NCT IDNCT07417735

SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Clinical Trials Information Group officer

031169085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Locally Advanced/Metastatic/Recurrent ESCC trials