Actively Recruiting
Safety and Efficacy of JS212 Combination Therapy in Advanced Esophageal Squamous Cell Carcinoma Patients: An Open-label, Multicenter Phase II Study
Led by Shanghai Junshi Bioscience Co., Ltd. · Updated on 2026-04-22
280
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of a combination therapy called JS212 in patients with advanced esophageal squamous cell carcinoma (ESCC) that cannot be treated with radical therapy. This open-label, phase II clinical trial is conducted across multiple centers and sponsored by Shanghai Junshi Bioscience Co., Ltd. The study focuses on patients with locally advanced, recurrent, or metastatic ESCC. The study includes two experimental groups: one receiving JS212 combined with JS001 every three weeks, and another receiving JS212, JS001 every three weeks plus 5-FU administered on days 1 and 8 of each three-week cycle. Treatments are given repeatedly according to these schedules to assess safety and response over time. The study does not use randomization or masking. Participants will be closely monitored for adverse events, dose-limiting toxicities, and objective tumor responses based on standard criteria over a period of up to four years. Researchers will also evaluate progression-free survival, overall survival, and immune response for up to two years. Patients must have measurable tumors and good performance status, and will undergo regular assessments to track their health and treatment effects throughout the study duration.
CONDITIONS
Brief Title
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 to 75 years at signing the consent form
- Histologically or cytologically confirmed esophageal squamous cell carcinoma that is locally advanced, recurrent, or metastatic and not suitable for radical treatment
- No prior systemic anti-tumor therapy; previous neoadjuvant/adjuvant therapy or chemoradiotherapy allowed if recurrence or progression occurred more than 6 months after last chemotherapy dose
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival of at least 12 weeks
You will not qualify if you...
- Prior treatment with anti-PD-1 or anti-PD-L1 antibodies, ADC therapy targeting EGFR/HER3, or ADC therapy with topoisomerase I inhibitor payload
- High risk of bleeding or esophageal fistula due to large ulcers or invasion of critical organs like aorta or trachea
- History of gastrointestinal perforation or fistula within 6 months before first dose
- Active central nervous system metastases
- Active autoimmune disease requiring systemic therapy within 2 years before first dose
- Unresolved toxicities from prior anti-tumor therapy above Grade 1 per CTCAE v6.0 or as specified
- Severe cardiovascular or cerebrovascular disease
- Known severe allergies to study drugs or their components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 years
Participants receive combination therapy with JS212, JS001, and optionally 5-FU administered every 3 weeks.
Visits every 3 weeks for drug administration
Duration - Up to 4 years
Participants are monitored for safety, efficacy, and survival outcomes after treatment.
Periodic visits during follow-up phase
Trial Site Locations
Total: 1 location
1
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chengbo Jia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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