Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT07484724
A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma
A Phase 2 study testing JS212, JS001 and 5-FU in people with Advanced Esophageal Squamous Cell Carcinoma, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- JS212, JS001 and 5-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2026to 1 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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；
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100142
Jing Huang, Ph.D, 010-87788102, huangjingwg@163.com
Jing Huang, Ph.D
About this study
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)
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).
- Being tested
- JS212, JS001, 5-FU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS212Drug
JS212 will be administered every 3 weeks
JS001Drug
JS001 will be administered every 3 weeks
5-FUDrug
5-FU will be administered on d1and d8 every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1:JS212+JS001 | Experimental | Not described Receives: Drug: JS212; Drug: JS001 |
| Cohort 2:JS212+JS001+5-FU | Experimental | Not described Receives: Drug: JS212; Drug: JS001; Drug: 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-limiting toxicity （DLT）
Abnormal changes in laboratory and other tests with clinical significance
Measured: up to 4 years
adverse event（AE）
Abnormal changes in laboratory and other tests with clinical significance
Measured: up to 4 years
RP3D
Recommended dose for phase III trial
Measured: up to 4 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Measured: up to 4 years
Secondary outcomes (3)
Progression free survival(PFS)
The time from first dose to Disease progression or death
Measured: up to 2years
overall survival (OS)
The time from first dose to death from any cause
Measured: up to 4 years
immunogenicity
Incidence of Anti-Drug Antibody (ADA)
Measured: up to 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start13 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484724
- Sponsor's protocol ID
- JS212-006-II-ESCC
- Status last verified
- Apr 2026
- First submitted
- 16 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No