Esophageal Squamous Cell CarcinomaPhase 2NCT07128693
A Single-center, Multicohort, Phase II Clinical Study Evaluating the Combination Therapy of Sacituzumab Tirumotecan in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
A Phase 2 study testing Sacituzumab Tirumotecan in combination with tislelizumab and Sacituzumab Tirumotecan in combination with anlotinib in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Sacituzumab Tirumotecan in combination with tislelizumab and Sacituzumab Tirumotecan in combination with anlotinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of informed consent signing.
- Diagnosed as unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma by histology/pathology.
- Cohort 1: Have never received any anti-tumor systemic treatment before, including but not limited to immunotherapy, targeted therapy, chemotherapy, etc. Cohort 2: Patients who have experienced progression or intolerance after receiving first-line systemic chemotherapy or chemotherapy combined with immunotherapy (which may include regimens based on platinum, taxanes or fluorouracil) (patients with progression after maintenance treatment following first-line chemotherapy can also be included).
- For patients with brain metastases, those who are asymptomatic or have stable symptoms of brain metastases are eligible for enrollment.
- The provision of tissue specimens is not mandatory. Patients can still be enrolled if there is no tissue specimen available.
- According to RECIST v1.1, the investigator should assess that there is at least one measurable target lesion that has not been irradiated.
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- ECOG performance status score of 0 or 1.
- Expected survival time ≥ 12 weeks.
- Adequate organ and bone marrow function(with no receipt of blood transfusions, recombinant human thrombopoietin, or colony-stimulating factors within two weeks prior to first drug administration), defined as follows:
- Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin ≥ 90g/L.
- Liver function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin (TBIL) ≤ 1.5 times ULN;
- Renal function: Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
- International Normalized Ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) values are ≤ 1.5 times the upper limit of normal (ULN).
- For female subjects of childbearing potential and male subjects with reproductive potential, a commitment to effective medical contraception is required from the date of informed consent signing through 6 months after the last dose administration.
- The subjects voluntarily joined this study, signed the informed consent form, and were able to comply with the visit and related procedures as stipulated in the protocol.
Who cannot join
- Having participated in other drug clinical trials within 4 weeks before enrollment.
- Cohort 1: Having previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Cohort 2: Having previously received anlotinib or other anti-angiogenic drugs; patients with tumor invasion of large blood vessels shown by imaging, or those judged to be highly likely to have tumors invading important blood vessels during the subsequent study period, leading to fatal massive bleeding; patients with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction.
- Patients with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
- A history of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
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- Known history of allergy to the drugs in this protocol and their components.
- Positive for human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- Vaccinated with live vaccine within 30 days before the first study drug administration.
- 7.A history of interstitial lung disease (ILD) or non-infectious pneumonia requiring corticosteroid therapy, or current ILD or non-infectious pneumonia, or suspected ILD or non-infectious pneumonia at screening that cannot be ruled out by imaging; clinically significant pulmonary impairment due to concurrent lung conditions, including but not limited to underlying pulmonary disorders (e.g., pulmonary embolism within 3 months prior to study entry, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion), autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.
- Active autoimmune diseases requiring systemic therapy within the past two years (hormone replacement therapy is excluded from systemic treatment, including conditions such as type 1 diabetes, hypothyroidism managed with thyroid hormone replacement alone, and adrenal or pituitary insufficiency treated solely with physiological doses of glucocorticoid replacement therapy).
- Active infections requiring systemic treatment within 2 weeks prior to the first dose administration.
- Concomitant diseases that, in the investigator's judgment, pose a significant risk to patient safety or may interfere with study completion, including but not limited to medication-uncontrolled hypertension, severe diabetes, or active infections.
- A documented history of severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or corneal disorders associated with delayed corneal healing.
- Female patients who are pregnant, lactating, or of childbearing potential with a positive baseline pregnancy test; female patients of childbearing age who are unwilling to adopt effective contraceptive measures during the treatment with the study drug and within 6 months after the last dose.
- Any other circumstances deemed by the investigator to make the patient unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Sacituzumab Tirumotecan in combination with tislelizumab, Sacituzumab Tirumotecan in combination with anlotinib
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab Tirumotecan in combination with tislelizumabDrug
Sacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity.
Tislelizumab，200 mg, iv, d1, Q3W, until disease progression or intolerable toxicity.
Sacituzumab Tirumotecan in combination with anlotinibDrug
Sacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity.
Anlotinib 12mg QD po d1-14，Q3W,until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| First-line treatment with Sacituzumab Tirumotecan in combination with tislelizumab | Experimental | First-line treatment with Sacituzumab Tirumotecan in combination with tislelizumab Receives: Drug: Sacituzumab Tirumotecan in combination with tislelizumab |
| Second-line treatment with Sacituzumab Tirumotecan in combination with anlotinib | Experimental | Second-line treatment with Sacituzumab Tirumotecan in combination with anlotinib Receives: Drug: Sacituzumab Tirumotecan in combination with anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.
Measured: Up to 24 months
Secondary outcomes (5)
ORR
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
Measured: Up to 24 months
DCR
DCR is defined as the proportion of subjects with complete response (CR), partial response (PR) and stable disease (SD) among all subjects.
Measured: Up to 24 months
DOR
DOR is defined as the time interval from the first documented disease response to disease progression or death (whichever occurs first)
Measured: Up to 24 months
OS
OS is defined as the time from the first receipt of treatment under the study protocol to the death of the subject due to any reason.
Measured: Up to 24 months
Adverse Events (AEs)
The number of participants experiencing an AE will be assessed
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng Wang, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128693
- Sponsor's protocol ID
- 2025-KY-0942
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Multicohort, Phase II Clinical Study Evaluating the Combination Therapy of Sacituzumab Tirumotecan in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07128693
- Acronym / sponsor ID
- 2025-KY-0942
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 Aug 2025 (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.
The aim of this study is to evaluate the efficacy and safety of the combined treatment with Sacituzumab Tirumotecan in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First-line treatment with Sacituzumab Tirumotecan in combination with tislelizumab | Experimental | Drug: Sacituzumab Tirumotecan in combination with tislelizumabFirst-line treatment with Sacituzumab Tirumotecan in combination with tislelizumab |
| Second-line treatment with Sacituzumab Tirumotecan in combination with anlotinib | Experimental | Drug: Sacituzumab Tirumotecan in combination with anlotinibSecond-line treatment with Sacituzumab Tirumotecan in combination with anlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years at the time of informed consent signing.
- Diagnosed as unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma by histology/pathology.
- Cohort 1: Have never received any anti-tumor systemic treatment before, including but not limited to immunotherapy, targeted therapy, chemotherapy, etc. Cohort 2: Patients who have experienced progression or intolerance after receiving first-line systemic chemotherapy or chemotherapy combined with immunotherapy (which may include regimens based on platinum, taxanes or fluorouracil) (patients with progression after maintenance treatment following first-line chemotherapy can also be included).
- For patients with brain metastases, those who are asymptomatic or have stable symptoms of brain metastases are eligible for enrollment.
- The provision of tissue specimens is not mandatory. Patients can still be enrolled if there is no tissue specimen available.
Key exclusion criteria (17 listed)
- Having participated in other drug clinical trials within 4 weeks before enrollment.
- Cohort 1: Having previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies, or any other antibodies or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Cohort 2: Having previously received anlotinib or other anti-angiogenic drugs; patients with tumor invasion of large blood vessels shown by imaging, or those judged to be highly likely to have tumors invading important blood vessels during the subsequent study period, leading to fatal massive bleeding; patients with bleeding tendencies such as acute gastrointestinal bleeding, persistent bleeding disorders, or coagulation dysfunction.
- Patients with multiple factors affecting oral drug administration (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.).
- Prior treatment with TROP2-targeted therapy and/or topoisomerase I inhibitors.
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 |
|---|---|---|
| Sacituzumab Tirumotecan in combination with tislelizumabSacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q3W, until disease progression or intolerable toxicity. | Drug | First-line treatment with Sacituzumab Tirumotecan in combination with tislelizumab |
| Sacituzumab Tirumotecan in combination with anlotinibSacituzumab Tirumotecan 5mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Anlotinib 12mg QD po d1-14，Q3W,until disease progression or intolerable toxicity. | Drug | Second-line treatment with Sacituzumab Tirumotecan in combination with anlotinib |
Primary outcome
PFS
Time frame: Up to 24 months
PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first.
5 secondary outcomes
ORR
Time frame: Up to 24 months
DCR
Time frame: Up to 24 months
DOR
Time frame: Up to 24 months
OS
Time frame: Up to 24 months
Adverse Events (AEs)
Time frame: Up to 24 months
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 19 Aug 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan in combination with tislelizumab and Sacituzumab Tirumotecan in combination with anlotinib in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.
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 15 inclusion and 17 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Feng Wang (+86-0371-66913114, zzuwangfeng@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Up to 24 months). 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 19 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.