Esophageal Squamous Cell CarcinomaPhase 2NCT07811752
Sacituzumab Govitecan Combined With Tislelizumab for Locally Advanced/Metastatic Esophageal Cancer
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) plus Tislelizumab in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 2 sites in China.
Trial summary
This is a prospective, single-center, single-arm Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with tislelizumab in patients with advanced esophageal squamous cell carcinoma whose disease has progressed following first-line immunotherapy. 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 (SKB264) plus Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jul 2026to 31 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
- Have voluntarily signed a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
- Be aged ≥18 years, regardless of sex.
- Have histologically or pathologically confirmed esophageal squamous cell carcinoma (ESCC) that is assessed as unsuitable for definitive treatment modalities (including definitive chemoradiotherapy and/or surgery) according to the American Joint Committee on Cancer (AJCC) TNM Staging System, 9th Edition.
- Have previously received first-line systemic therapy consisting of an immune checkpoint inhibitor in combination with chemotherapy and have experienced radiographically confirmed disease progression during or after such treatment.
- Have at least one measurable lesion as defined by RECIST version 1.1, as assessed by the investigator, which has not been previously treated with radiotherapy.
- Have an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
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- Have a life expectancy of at least 12 weeks.
- Have adequate organ and bone marrow function, without receiving blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to the first dose, as defined by all of the following laboratory criteria:
- Hematologic function:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin ≥ 90 g/L.
- Hepatic function:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); For subjects with baseline liver metastases, AST and ALT ≤ 5 × ULN; Serum albumin ≥ 30 g/L; Total bilirubin (TBIL) ≤ 1.5 × ULN.
- Renal function:
- Creatinine clearance ≥ 50 mL/min, calculated using the Cockcroft-Gault formula.
- Coagulation function:
- International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN.
- For women of childbearing potential and men with partners of childbearing potential, agree to use highly effective contraception from signing the informed consent form until 6 months after the last dose of study treatment.
- Be willing and able to comply with all protocol-specified visits, treatment plans, laboratory tests, and other study procedures, and voluntarily participate in the study by providing written informed consent.
Who cannot join
- Prior placement of an esophageal or tracheal stent.
- Presence of a high risk of bleeding or perforation due to obvious tumor invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea), or the presence of a fistula.
- Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
- Prior treatment with any TROP2-targeted therapy and/or topoisomerase I inhibitors.
- Any of the following events during prior first-line treatment with a PD-1/PD-L1 inhibitor:
- 1)Disease progression within 3 months after initiation of treatment; History of Grade ≥3 treatment-related adverse events, Grade 2 immune-related cardiotoxicity, or any grade neurologic or ophthalmologic adverse events related to PD-1/PD-L1 inhibitors; 2)Any adverse event from prior PD-1/PD-L1 inhibitor therapy that had not completely resolved or had not improved to Grade 1 or below before study screening; 3)History of adverse events requiring immunosuppressive treatment other than corticosteroids.
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- 6.History of another malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or cutaneous squamous cell carcinoma.
- 7.Known hypersensitivity to any study drug or any of its excipients.
- 8.Positive test for human immunodeficiency virus (HIV), history of acquired immunodeficiency syndrome (AIDS), or known active syphilis infection.
- 9.Active autoimmune disease requiring systemic treatment within 2 years prior to initiation of study treatment, or autoimmune disease considered by the investigator to have a risk of recurrence or require future treatment.
- 10.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- 11.Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
- 12.Any of the following pulmonary conditions:History of interstitial lung disease (ILD) or non-infectious pneumonitis requiring corticosteroid treatment; Current ILD or non-infectious pneumonitis;Suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening;Clinically significant pulmonary impairment due to concurrent pulmonary diseases, including but not limited to pulmonary embolism within 3 months prior to first dosing, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, or autoimmune/connective tissue/inflammatory diseases involving the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis);Prior pneumonectomy.
- 13.Active autoimmune disease that required systemic treatment within the previous 2 years. Hormone replacement therapy is not considered systemic treatment, including:Type 1 diabetes mellitus;Hypothyroidism requiring only thyroid hormone replacement therapy;Adrenal or pituitary insufficiency requiring only physiologic corticosteroid replacement therapy.
- 14.Active infection requiring systemic therapy within 2 weeks prior to the first study dose.
- 15.Any severe concomitant disease that, in the investigator's judgment, may compromise subject safety or interfere with study participation, including but not limited to uncontrolled hypertension, severe diabetes mellitus, or active infection.
- 16.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disorders that may delay corneal healing.
- 17.Women who are pregnant or breastfeeding; women of childbearing potential with a positive pregnancy test at baseline; or women of childbearing potential unwilling to use highly effective contraception during study treatment and for 6 months after the last dose of study treatment.
- 18.Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai
Jun Liu, +86 21-2220000 ext. 3602, drjunliuplus@163.com
- Recruiting
Shanghai Chest Hospital
Shanghai
Jun Liu, +86-21-2220000 ext. 3602, drjunliuplus@163.com
About this study
Official title: The Efficacy and Safety of Sacituzumab Govitecan Plus Tislelizumab in Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Patients Who Progressed on Prior Immune Checkpoint Inhibitors (ICIs)
This is a prospective, single-center, single-arm Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with tislelizumab in patients with advanced esophageal squamous cell carcinoma whose disease has progressed following first-line immunotherapy.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Sacituzumab Tirumotecan (SKB264) plus Tislelizumab
- 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 (SKB264) plus TislelizumabDrug
Sacituzumab Tirumotecan 4mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity.
Tislelizumab，200 mg, iv, d1, Q2W, until disease progression or intolerable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Tirumotecan in combination with tislelizumab | Experimental | Sacituzumab Tirumotecan 4mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity.
Tislelizumab，200 mg, iv, d1, Q2W, until disease progression or intolerable toxicity. Receives: Drug: Sacituzumab Tirumotecan (SKB264) plus Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Secondary outcomes (5)
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
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 posted10 Sep 2026
- Study start30 Jul 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811752
- Sponsor's protocol ID
- ShanghaiChest ESO
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu X, Ma X, Li H, Zhang M, Cheng Y, Wu J, Yu W, Feng W, Zhao L, Li Z, Fu X, Liu J. The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096). Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
PubMed 39711430Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.
PubMed 37080222Xiong A, Yao W, Zheng W, Yu Y, Chen P, Zhong H, Ge J, Wang H, Chen B, Wang H, Fan Y, Yang Y, Pu X, Song X, Wang Q, Du X, Huang Z, Li X, Luo H, Yao Y, Yu Q, Su C, He L, Jiang G, Cui J, Liu C, Yi T, Che G, Liu Z, Zhang L, Zhou M, Fang Y, Wei Y, Qing Y, Jin X, Zhou C. Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. Lancet. 2026 Jun 27;407(10548):2607-2619. doi: 10.1016/S0140-6736(26)00968-2. Epub 2026 May 29.
PubMed 42214392
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Sacituzumab Govitecan Plus Tislelizumab in Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC) Patients Who Progressed on Prior Immune Checkpoint Inhibitors (ICIs)
- ClinicalTrials.gov ID
- NCT07811752
- Acronym / sponsor ID
- ShanghaiChest ESO
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Sep 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 is a prospective, single-center, single-arm Phase II clinical study designed to evaluate the efficacy and safety of sacituzumab tirumotecan in combination with tislelizumab in patients with advanced esophageal squamous cell carcinoma whose disease has progressed following first-line immunotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Tirumotecan in combination with tislelizumab | Experimental | Drug: Sacituzumab Tirumotecan (SKB264) plus TislelizumabSacituzumab Tirumotecan 4mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q2W, until disease progression or intolerable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Have voluntarily signed a written informed consent form (ICF) prior to the initiation of any study-specific procedures.
- Be aged ≥18 years, regardless of sex.
- Have histologically or pathologically confirmed esophageal squamous cell carcinoma (ESCC) that is assessed as unsuitable for definitive treatment modalities (including definitive chemoradiotherapy and/or surgery) according to the American Joint Committee on Cancer (AJCC) TNM Staging System, 9th Edition.
- Have previously received first-line systemic therapy consisting of an immune checkpoint inhibitor in combination with chemotherapy and have experienced radiographically confirmed disease progression during or after such treatment.
- Have at least one measurable lesion as defined by RECIST version 1.1, as assessed by the investigator, which has not been previously treated with radiotherapy.
Key exclusion criteria (19 listed)
- Prior placement of an esophageal or tracheal stent.
- Presence of a high risk of bleeding or perforation due to obvious tumor invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea), or the presence of a fistula.
- Participation in another interventional drug clinical trial within 4 weeks prior to enrollment.
- Prior treatment with any TROP2-targeted therapy and/or topoisomerase I inhibitors.
- Any of the following events during prior first-line treatment with a PD-1/PD-L1 inhibitor:
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 (SKB264) plus TislelizumabSacituzumab Tirumotecan 4mg/kg, iv, d1, Q2W ,until disease progression or intolerable toxicity. Tislelizumab，200 mg, iv, d1, Q2W, until disease progression or intolerable toxicity. | Drug | Sacituzumab Tirumotecan in combination with tislelizumab |
Primary outcome
ORR
Time frame: Up to 24 months
ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.
5 secondary outcomes
PFS
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 10 Sep 2026.
- Background: PubMed 39711430Zhu X, Ma X, Li H, Zhang M, Cheng Y, Wu J, Yu W, Feng W, Zhao L, Li Z, Fu X, Liu J. The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096). Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
- Background: PubMed 37080222Xu J, Kato K, Raymond E, Hubner RA, Shu Y, Pan Y, Park SR, Ping L, Jiang Y, Zhang J, Wu X, Yao Y, Shen L, Kojima T, Gotovkin E, Ishihara R, Wyrwicz L, Van Cutsem E, Jimenez-Fonseca P, Lin CY, Wang L, Shi J, Li L, Yoon HH. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (RATIONALE-306): a global, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2023 May;24(5):483-495. doi: 10.1016/S1470-2045(23)00108-0. Epub 2023 Apr 17.
- Background: PubMed 42214392Xiong A, Yao W, Zheng W, Yu Y, Chen P, Zhong H, Ge J, Wang H, Chen B, Wang H, Fan Y, Yang Y, Pu X, Song X, Wang Q, Du X, Huang Z, Li X, Luo H, Yao Y, Yu Q, Su C, He L, Jiang G, Cui J, Liu C, Yi T, Che G, Liu Z, Zhang L, Zhou M, Fang Y, Wei Y, Qing Y, Jin X, Zhou C. Sacituzumab tirumotecan plus pembrolizumab versus pembrolizumab in PD-L1-positive advanced non-small-cell lung cancer (OptiTROP-Lung05): interim analysis of a randomised, open-label, phase 3 trial. Lancet. 2026 Jun 27;407(10548):2607-2619. doi: 10.1016/S0140-6736(26)00968-2. Epub 2026 May 29.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Tirumotecan (SKB264) plus Tislelizumab in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 2 sites 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 18 inclusion and 19 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jun Liu (+86-21-2220000 ext. 3602, drjunliuplus@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (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?
On the ClinicalTrials.gov record for NCT07811752, which also lists 3 linked publications.
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 10 Sep 2026.