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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07484724
- Acronym / sponsor ID
- JS212-006-II-ESCC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1:JS212+JS001 | Experimental | Drug: JS212, Drug: JS001 |
| Cohort 2:JS212+JS001+5-FU | Experimental | Drug: JS212, Drug: JS001, Drug: 5-FU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS212JS212 will be administered every 3 weeks | Drug | Cohort 1:JS212+JS001, Cohort 2:JS212+JS001+5-FU |
| JS001JS001 will be administered every 3 weeks | Drug | Cohort 1:JS212+JS001, Cohort 2:JS212+JS001+5-FU |
| 5-FU5-FU will be administered on d1and d8 every 3 weeks | Drug | Cohort 2:JS212+JS001+5-FU |
Primary outcome
dose-limiting toxicity （DLT）
Time frame: up to 4 years
Abnormal changes in laboratory and other tests with clinical significance
adverse event（AE）
Time frame: up to 4 years
Abnormal changes in laboratory and other tests with clinical significance
RP3D
Time frame: up to 4 years
Recommended dose for phase III trial
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Time frame: up to 4 years
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
3 secondary outcomes
Progression free survival(PFS)
Time frame: up to 2years
overall survival (OS)
Time frame: up to 4 years
immunogenicity
Time frame: up to 2years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chengbo Jia (+8618547265054, chengbo_jia@junpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose-limiting toxicity （DLT） (time frame: up to 4 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.