NCT07251062Not yet recruitingPhase 2/3
A Study of SYS6010, Enlonstobart, and Chemotherapy for First-Line Treatment of Esophageal Squamous Cell Carcinoma.
A Phase II/III Study to Evaluate the Efficacy and Safety of SYS6010 in Combination With SG001 With or Without 5-FU/Capecitabine in Subjects With First-Line Advanced/Metastatic Esophageal Squamous Cell Carcinoma.
Source: ClinicalTrials.gov · Last updated 26 Nov 2025
Brief summary (registry, in English)
This is a multicenter phase 2/3 clinical study to evaluate the efficacy and safety of SYS6010 plus SG001±5-FU/Capecitabine as first-line treatment, in patients with advanced/metastatic esophageal squamous cell carcinoma.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 737 (estimated)
- First submitted
- 13 Nov 2025
- Start date
- 30 Dec 2025
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07251062
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 737
- From 30 Dec 2025 to the primary completion date, 30 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment involving topoisomerase I inhibitors (including ADC drugs that contain topoisomerase I inhibitors as toxins);
- Prior treatment with immune checkpoint inhibitors or other agents targeting T-cell co-stimulatory/co-inhibitory pathways (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, anti-CD137 antibodies)
Other illness
- With a history of ≥Grade 3 allergic reactions to monoclonal antibodies, or with known hypersensitivity or intolerance to SYS6010, SG001, paclitaxel, carboplatin, cisplatin, fluorouracil, or any of their excipients;
Other
- With dihydropyrimidine dehydrogenase (DPD) deficiency.
Who the study is looking for
- Be able to understand and voluntarily sign the written ICF;
- Age 18-75 (inclusive) years, male or female;
- With histologically/cytologically confirmed esophageal squamous cell carcinoma that is either locally advanced unresectable or metastatic, with no prior systemic antitumor therapy administered for the recurrent/metastatic disease setting. Have at least one measurable lesion that meets the RECIST v 1.1 criteria at baseline;
- Eastern Cooperative Oncology Group (ECOG) performance status score: 0-1;
- Life expectancy ≥ 3 months;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.