Recruiting NCT07484724
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: JS212, JS001, 5-FU.
- Who it may be relevant to
- Registry conditions: Advanced Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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).
Interventions
- Drug JS212
JS212 will be administered every 3 weeks - Drug JS001
JS001 will be administered every 3 weeks - Drug 5-FU
5-FU will be administered on d1and d8 every 3 weeks
Primary outcome measures
- dose-limiting toxicity （DLT） [Time frame: up to 4 years]
- adverse event（AE） [Time frame: up to 4 years]
- RP3D [Time frame: up to 4 years]
- Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) [Time frame: up to 4 years]
Secondary outcome measures (3)
- Progression free survival(PFS) [Time frame: up to 2years]
- overall survival (OS) [Time frame: up to 4 years]
- immunogenicity [Time frame: up to 2years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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;
- Toxicities from prior anti-tumor therapy have not recovered to ≤ Grade 1 per CTCAE v6.0 or to the level specified in the inclusion/exclusion criteria;
- Severe cardiovascular or cerebrovascular disease;
- Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital of Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07484724 · JS212-006-II-ESCC