JS212 plus JS001 and 5‑FU for advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, multi‑center phase II trial testing the safety and preliminary efficacy of a combination regimen (JS212, JS001, and 5‑FU) in patients with locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma not amenable to curative treatment. Eligible participants are adults 18–75 with histologically confirmed ESCC, at least one measurable lesion by RECIST 1.1, ECOG performance status 0–1, and no prior systemic anti‑tumor therapy (with specified exceptions for prior adjuvant/neoadjuvant therapy). The study will monitor safety, tolerability, and tumor responses using standard imaging and RECIST criteria, with expected follow‑up for preliminary efficacy endpoints. Patients previously treated with anti‑PD‑1/PD‑L1 antibodies or certain ADC therapies are excluded to avoid confounding prior immune or targeted exposures.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female subjects aged 18 to 75 years (inclusive) at the time of signing the Informed Consent Form (ICF).
2. Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC) that is locally advanced, recurrent, or metastatic, and not amenable to radical treatment.
3. 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.
4. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Expected survival ≥ 12 weeks

Exclusion Criteria:

1. 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;
2. 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;
3. Subjects with a history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose;
4. Presence of active central nervous system (CNS) metastases;
5. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive agents) within 2 years prior to the first dose;
6. 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;
7. Severe cardiovascular or cerebrovascular disease;
8. Known hypersensitivity or severe allergic reaction to the study treatment drugs, any of their components, or their excipients；

Where it's running

• Cancer Hospital of Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Chengbo Jia
• Email: chengbo_jia@junpharma.com
• Phone: +8618547265054

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.