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

NCT07417735 | Not Yet Recruiting Phase 3

• 1 other identifier: SYS6010-019
• Study Type: interventional
• Target: 436
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Locally Advanced/Metastatic/Recurrent ESCC

Outcome Measures

Primary Outcomes (2)

• 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.

  Up to 2 years

• 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.

  Up to 2 years

Secondary Outcomes (9)

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DOR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Clinical Benefit Rate（CBR）

  Up to 2 years

• PFS assessed by Investigators based on RECIST 1.1 criteria

  Up to 2 years

Study Arms (2)

SYS6010

EXPERIMENTAL

SYS6010 monotherapy

Drug: SYS6010

Chemotherapy

ACTIVE COMPARATOR

Investigator's choice of one chemotherapy treatment (Irinotecan hydrochloride，Paclitaxel，Docetaxel

Drug: Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)

Interventions

SYS6010 DRUG

SYS6010 IV

SYS6010

Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel) DRUG

Investigator'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）

Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male participants and female participants of childbearing potential must agree to adopt effective contraceptive measures from the time of signing the ICF until 7 months after the last dose; during this period, female participants must not be breastfeeding and male participants must refrain from sperm donation. Female participants of childbearing potential must have a negative blood pregnancy test within 7 days prior to randomization.

You may not qualify if:

• 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.
• Prior receipt of treatment with irinotecan-containing drugs or topoisomerase Ⅰ inhibitor-toxin antibody-drug conjugate (ADC) products.
• Body mass index (BMI) \< 16.0 kg/m\^2 or body weight \< 40 kg.
• A history of any other active malignant tumor within 5 years (except for radically resected and non-recurrent basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, superficial bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, or other carcinomas in situ).
• Presence of bleeding diathesis; active bleeding, hemoptysis, or a history of major bleeding within the past 6 months; imaging (CT or MRI) showing tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade major blood vessels during the subsequent study period leading to fatal massive bleeding.
• Presence of any severe and/or uncontrolled disease prior to randomization, including but not limited to:
• Myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] class ≥ Ⅱ), unstable angina pectoris, coronary angioplasty, or bypass surgery within 6 months prior to randomization;
• Left ventricular ejection fraction (LVEF) \< 50% as indicated by echocardiography during screening;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants in this trial will be randomly assigned to one of two groups.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02