Locally Advanced/Metastatic/Recurrent ESCCPhase 3NCT07417735
SYS6010 Versus Chemotherapy in Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma
A Phase 3 study testing SYS6010 and Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel) in people with Locally Advanced/Metastatic/Recurrent ESCC, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced/Metastatic/Recurrent ESCC
- What is being tested?
- SYS6010 and Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 32Show fewer
- 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;
- Arterial/deep venous thrombosis/cancer-associated thrombosis events (e.g., cerebrovascular accident including transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep venous thrombosis, pulmonary embolism, etc.) within 6 months prior to randomization;
- Uncontrolled serous cavity effusions requiring repeated drainage (e.g., pleural effusion, ascites, pericardial effusion, etc.);
- Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg with medical management) or a history of hypertensive crisis/hypertensive encephalopathy;
- Corrected QT interval using Fridericia's formula (QTcF) ≥ 450 ms in males and QTcF ≥ 470 ms in females; or a diagnosis of congenital long QT syndrome, and/or known concomitant use of drugs that prolong the QT interval;
- Severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, third-degree atrioventricular block, etc.);
- Clinically significant severe electrolyte abnormalities requiring medical treatment as judged by the investigator;
- Poorly controlled diabetes mellitus (fasting blood glucose > 10.0 mmol/L).
- Active viral hepatitis (positive HBsAg with HBV-DNA ≥ 10^4 cps/mL or ≥ 2000 IU/mL; positive HCV antibody with positive HCV viral titer); human immunodeficiency virus antibody (HIV-Ab) positive subjects; active syphilis infection (positive Treponema pallidum antibody with positive Rapid Plasma Reagin [RPR] or Toluidine Red Unheated Serum Test [TRUST]).
- A past history of interstitial lung disease (ILD)/non-infectious pneumonia requiring glucocorticoid therapy, current ILD/non-infectious pneumonia, or inability to rule out ILD/non-infectious pneumonia by imaging examination during screening.
- A history of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization; or obvious ulceration of the esophageal lesion, tumor invasion of adjacent tissues, or imaging evidence of a risk of tracheoesophageal fistula, and the investigator judges the subject to be unsuitable for anti-angiogenic drug therapy.
- A past or current history of mental disorders or epilepsy requiring treatment.
- Infection requiring systemic anti-infective therapy within 2 weeks prior to randomization (except for uncomplicated urinary tract infection or upper respiratory tract infection).
- Presence of clinically significant gastrointestinal diseases during screening, including bleeding, inflammation, obstruction, intractable vomiting (defined as ≥ 3 episodes of vomiting within 24 hours), and diarrhea of grade > 1.
- Ingestion of strong CYP3A4 inducers or inhibitors, or OATP1B1/OATP1B3 inhibitors within 2 weeks prior to randomization, or anticipated need for the above drugs during the trial period.
- Failure of adverse reactions from prior chemotherapy, surgery, radiotherapy, or other anti-tumor therapies to resolve to ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0 or baseline levels (except for toxicities with no safety risk as judged by the investigator, such as alopecia).
- Presence of skin diseases requiring oral or intravenous drug therapy during screening, and the investigator judges the subject to be unsuitable for study drug administration.
- Other conditions that the investigator deems unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SYS6010 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma Who Have Failed at Least One Line of Systemic Therapy.
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
- Being tested
- SYS6010, Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010Drug
SYS6010 IV
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）
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 | Experimental | SYS6010 monotherapy Receives: Drug: SYS6010 |
| Chemotherapy | Active comparator | Investigator's choice of one chemotherapy treatment (Irinotecan hydrochloride，Paclitaxel，Docetaxel Receives: Drug: Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 years
Secondary outcomes (9)
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.
Measured: Up to 2 years
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.
Measured: Up to 2 years
Disease Control Rate (DCR)
The percentage of participants who experience a best response of CR, PR or stable disease (SD).
Measured: Up to 2 years
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.
Measured: Up to 2 years
PFS assessed by Investigators based on RECIST 1.1 criteria
Measured: Up to 2 years
Incidence of adverse events
Measured: Up to 2 years
PK characteristics of SYS6010
Measured: Up to 2 years
Anti-Drug Antibody (ADA) of SYS6010
Measured: Up to 2 years
EGFR protein expression
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced/Metastatic/Recurrent ESCCStudies of the same condition, open and under way.
- More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in this trial will be randomly assigned to one of two groups.
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417735
- Sponsor's protocol ID
- SYS6010-019
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multicenter Phase Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SYS6010 Versus Investigator's Choice Chemotherapy in Patients With Locally Advanced or Metastatic/Recurrent Esophageal Squamous Cell Carcinoma Who Have Failed at Least One Line of Systemic Therapy.
- ClinicalTrials.gov ID
- NCT07417735
- Acronym / sponsor ID
- SYS6010-019
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 436 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants in this trial will be randomly assigned to one of two groups.
| Arm | Type | Receives |
|---|---|---|
| SYS6010 | Experimental | Drug: SYS6010SYS6010 monotherapy |
| Chemotherapy | Active comparator | Drug: Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)Investigator's choice of one chemotherapy treatment (Irinotecan hydrochloride，Paclitaxel，Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (32 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6010SYS6010 IV | Drug | SYS6010 |
| Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel)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） | Drug | Chemotherapy |
Primary outcome
Progression Free Survival (PFS) Assessed by Blinded Independent Central Review(BICR) According to the RECIST 1.1 Criteria
Time frame: Up to 2 years
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)
Time frame: Up to 2 years
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.
9 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Clinical Benefit Rate（CBR）
Time frame: Up to 2 years
PFS assessed by Investigators based on RECIST 1.1 criteria
Time frame: Up to 2 years
Incidence of adverse events
Time frame: Up to 2 years
PK characteristics of SYS6010
Time frame: Up to 2 years
Anti-Drug Antibody (ADA) of SYS6010
Time frame: Up to 2 years
EGFR protein expression
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Related trials for Locally Advanced/Metastatic/Recurrent ESCC
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 3
FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.
Locally Advanced, Recurrent or Metastatic ESCC Patients Who Have Failed Prior PD-1/PD-L1 Inhibitors Combined With Platinum-based Chemotherapy
RecruitingPhase 3
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Esophageal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SYS6010 and Investigator's Choice of Chemotherapy (Irinotecan hydrochloride，Paclitaxel，Docetaxel) in people with Locally Advanced/Metastatic/Recurrent ESCC, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) Assessed by Blinded Independent Central Review(BICR) According to the RECIST 1.1 Criteria (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.