RecruitingPhase 2

A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma

China280 participantsStarted 2026-04-13

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

What they're measuring

dose-limiting toxicity （DLT）

Timeframe: up to 4 years

adverse event（AE）

Timeframe: up to 4 years

RP3D

Timeframe: up to 4 years

Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)

Timeframe: up to 4 years

Trial details

NCT IDNCT07484724

SponsorShanghai Junshi Bioscience Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Chengbo Jia

+8618547265054 chengbo_jia@junpharma.com

View on ClinicalTrials.gov More Advanced Esophageal Squamous Cell Carcinoma trials

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;