A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Shanghai Junshi Bioscience Co., Ltd.
280 participants
Apr 13, 2026
INTERVENTIONAL
Conditions
Summary
This study is an open-label, multi-center phase II clinical trial aimed to evaluat the safety and preliminary efficacy of JS212 combination therapy in patients with advanced esophageal squamous cell carcinoma (ESCC).
Eligibility
Inclusion Criteria6
- Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).
- Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.
- No prior systemic anti-tumor therapy. For patients who received neoadjuvant/adjuvant therapy or radical concurrent chemoradiotherapy, the interval from the last dose of chemotherapy to disease recurrence or progression must be > 6 months to be eligible for screening.
- At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Expected survival ≥ 12 weeks
Exclusion Criteria7
- Prior treatment with any of the following: anti-PD-1 or anti-PD-L1 antibody therapy; ADC therapy targeting EGFR and/or HER3, or ADC therapy with a topoisomerase I inhibitor as the toxic payload;
- Subjects at high risk of bleeding or esophageal fistula, e.g., lesions with large ulcers or direct invasion of vital adjacent organs such as the aorta or trachea;
- Subjects with a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose;
- Presence of active central nervous system (CNS) metastases;
- Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;
- Severe cardiovascular or cerebrovascular disease;
- Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；
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Interventions
JS212 will be administered every 3 weeks
JS001 will be administered every 3 weeks
5-FU will be administered on d1and d8 every 3 weeks
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07484724