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Esophageal Squamous Cell CarcinomaPhase 2NCT07823270

Neoadjuvant Sacituzumab Tirumotecan Plus Toripalimab in Locally Advanced Esophageal Squamous Cell Carcinoma

A Phase 2 study testing Sacituzumab tirumotecan and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study aims to evaluate the efficacy and safety of neoadjuvant sacituzumab tirumotecan (SKB264/MK-2870) combined with toripalimab in patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC). 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 and Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
Oct 2026to Dec 2030
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, either sex.
  • Histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma.
  • Judged by imaging and esophagoscopy as resectable and requiring neoadjuvant therapy, with clinical stage cT1-2N+M0 or T3-4N0-3M0 (stage II-IVA).
  • No prior antitumor therapy for esophageal squamous cell carcinoma.
  • At least one measurable lesion per RECIST v1.1.
  • ECOG performance status of 0 or 1 within 7 days before dosing.
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  • Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor within 2 weeks before the first dose):
  • Hematology: NEUT# >=1.5x10^9/L; PLT >=100x10^9/L; hemoglobin >=90 g/L.
  • Hepatic: AST and ALT <=2.5xULN (<=5xULN for participants with baseline liver metastases); albumin >=30 g/L; total bilirubin <=1.5xULN.
  • Renal: creatinine clearance >=60 mL/min (Cockcroft-Gault formula).
  • Coagulation: INR, APTT, and PT <=1.5xULN.
  • Normal thyroid function, defined as TSH within the normal range. If baseline TSH is outside the normal range, participants with total T3 (or FT3) and FT4 within the normal range are also eligible.
  • Cardiac enzymes within the normal range (isolated laboratory abnormalities judged by the investigator as not clinically significant are allowed).
  • Left ventricular ejection fraction >=55%.
  • Women of childbearing potential and men with partners of childbearing potential must agree to use effective medical contraception from informed consent until 6 months after the last dose.
  • Participants voluntarily join the study, sign the informed consent form, and are able to comply with the scheduled visits and procedures.

Who cannot join

  • Any prior antitumor therapy for the currently diagnosed esophageal squamous cell carcinoma.
  • History of other malignancies within 5 years (except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and carcinoma in situ of the cervix).
  • Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose or during the study.
  • Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that interferes with or delays corneal healing.
  • Any of the following cardiovascular or cerebrovascular diseases or risk factors:
  • Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, grade 3 or 4 heart failure (NYHA classification), symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient ischemic attack, or other severe cardiovascular or cerebrovascular diseases within 6 months before dosing.
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  • History of myocarditis, primary cardiomyopathy, or specific cardiomyopathy.
  • Any deep vein thrombosis (participants stabilized with low molecular weight heparin or similar therapy for >=2 weeks may be allowed), peripheral arterial thromboembolic event, pulmonary embolism, or other severe thromboembolic events within 3 months before dosing.
  • Aortic aneurysm, aortic dissecting aneurysm, or other major vascular disease that may be life-threatening or requires surgery within 6 months before dosing.
  • Uncontrolled systemic disease as judged by the investigator:
  • Poorly controlled diabetes mellitus (two consecutive fasting glucose levels >=9 mmol/L).
  • Poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg).
  • Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • History of steroid-requiring (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis; current ILD or non-infectious pneumonitis; or suspected ILD or non-infectious pneumonitis that cannot be excluded by imaging at screening.
  • Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying drugs, immunosuppressants, or systemic corticosteroids (>10 mg/day prednisone or equivalent). Hormone replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency is not considered systemic treatment. Participants receiving systemic corticosteroids >10 mg/day prednisone or other immunosuppressive drugs within 2 weeks before dosing.
  • Known active pulmonary tuberculosis. Participants with suspected active pulmonary tuberculosis must undergo clinical evaluation to exclude it.
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Active hepatitis B (HBsAg positive with HBV-DNA >=500 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C (HCV antibody positive with HCV-RNA above the lower limit of detection). Participants who are HBsAg positive are required to receive anti-hepatitis B viral therapy during the study.
  • Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
  • Known hypersensitivity to the study drugs or any of their components, or a history of severe hypersensitivity reactions to other biologics.
  • Severe infection within 4 weeks before dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks before dosing.
  • Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or Chinese patent medicines approved for antitumor indications within 2 weeks before dosing.
  • Receipt of a live vaccine within 30 days before dosing, or planned receipt of a live vaccine during the study.
  • Rapid deterioration during screening before dosing, such as a marked change in performance status.
  • Pregnant or breastfeeding women.
  • Local or systemic diseases caused by non-malignant conditions, or diseases or symptoms secondary to the tumor, that may lead to high medical risk and/or uncertainty in survival evaluation, such as leukemoid reaction or cachexia.
  • Any condition that, in the investigator's judgment, interferes with the evaluation of the study drug, participant safety, or interpretation of study results, or any other condition that makes the participant unsuitable for this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhenhua Li contact

+86 185 3111 5825

China1 site

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, Hebei, 050011

Other trials in China

About this study

Official title: A Prospective, Single-arm, Phase II Study of Neoadjuvant Sacituzumab Tirumotecan (SKB264/MK-2870) Combined With Toripalimab in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

This study aims to evaluate the efficacy and safety of neoadjuvant sacituzumab tirumotecan (SKB264/MK-2870) combined with toripalimab in patients with locally advanced, resectable esophageal squamous cell carcinoma (ESCC). Eligible participants will receive 3 cycles of neoadjuvant treatment, followed by radical surgery. The primary endpoint is the pathologic complete response (pCR) rate.

Read the detailed description

This is a prospective, single-arm, phase II study planned to enroll 33 participants with histologically or cytologically confirmed locally advanced esophageal squamous cell carcinoma (clinical stage cT1-2N+M0 or T3-4N0-3M0, stage II-IVA) who are candidates for surgery and require neoadjuvant therapy. After screening within 28 days before the first dose, eligible participants will receive sacituzumab tirumotecan 4 mg/kg intravenously once every 2 weeks on day 1 for 3 cycles, in combination with toripalimab 3 mg/kg intravenously once every 2 weeks on day 1 for 3 cycles. When administered on the same day, toripalimab is infused first, followed by sacituzumab tirumotecan after an interval of at least 30 minutes. Tumor response will be assessed based on RECIST v1.1, and radical surgery will be performed within 28 days after completion of neoadjuvant therapy. Tumor assessments will be performed every 3 months for the first 2 years after surgery and every 6 months thereafter until radiologically confirmed disease progression. Survival follow-up will be conducted every 3 to 6 months by telephone. Safety will be assessed according to NCI CTCAE v5.0.

Being tested
Sacituzumab tirumotecan, Toripalimab
Keywords
esophageal squamous cell carcinoma, neoadjuvant therapy, TROP2 antibody-drug conjugate
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 tirumotecanDrug

    4 mg/kg administered intravenously on day 1 of each 14-day cycle for 3 cycles. Premedication is required before each infusion to prevent infusion-related reactions.

  • ToripalimabDrug

    3 mg/kg administered intravenously on day 1 of each 14-day cycle for 3 cycles. When given on the same day, toripalimab is infused first, followed by sacituzumab tirumotecan after an interval of at least 30 minutes.

Study groups in NCT07823270
Study groupRoleWhat they receive
Neoadjuvant Sacituzumab Tirumotecan + ToripalimabExperimentalParticipants receive sacituzumab tirumotecan 4 mg/kg intravenously once every 2 weeks plus toripalimab 3 mg/kg intravenously once every 2 weeks for 3 cycles, followed by radical surgery.
Receives: Drug: Sacituzumab tirumotecan; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathologic complete response (pCR) rate

    The proportion of participants with no residual viable tumor cells in the resected primary tumor and regional lymph nodes (ypT0N0) after neoadjuvant therapy, as assessed by central pathologic review.

    Measured: Approximately 3 months after the first dose (after completion of neoadjuvant therapy and radical surgery)

Secondary outcomes (5)

  1. Major pathologic response (MPR) rate

    The proportion of participants with 10 percent or fewer viable tumor cells remaining in the resected primary tumor and regional lymph nodes after neoadjuvant therapy.

    Measured: Approximately 3 months after the first dose(after completion of neoadjuvant therapy and radical surgery)

  2. Objective response rate (ORR) per RECIST v1.1

    The proportion of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST v1.1.

    Measured: Approximately 3 months after the first dose

  3. Event-free survival (EFS)

    Time from the first dose to any of the following events: any disease progression that precludes surgery, postoperative disease progression or recurrence, or death from any cause, whichever occurs first, as assessed by the investigator according to RECIST v1.1.

    Measured: From the first dose until the event, assessed up to approximately 3 years

  4. Overall survival (OS)

    Time from the first dose to death from any cause.

    Measured: From the first dose until death from any cause, assessed up to approximately 5 years

  5. Incidence and severity of adverse events (safety and tolerability)

    Incidence, severity, and relationship to study treatment of all adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs) graded according to NCI CTCAE v5.0; the proportion of participants requiring dose reduction or discontinuation due to AEs; and changes in vital signs, physical examination findings, and laboratory results.

    Measured: From the first dose until 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07823270
Sponsor's protocol ID
ESCC-IIT-JS001-N08
Status last verified
Sep 2026
First submitted
11 Sep 2026
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F. Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial. Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.

    PubMed 35245446

  • Yang H, Liu H, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J, Han Y, Chen Z, Yang H, Wang J, Pang Q, Zheng X, Yang H, Li T, Zhang X, Li Q, Wang G, Chen B, Mao T, Kong M, Guo X, Lin T, Liu M, Fu J. Long-term Efficacy of Neoadjuvant Chemoradiotherapy Plus Surgery for the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma: The NEOCRTEC5010 Randomized Clinical Trial. JAMA Surg. 2021 Aug 1;156(8):721-729. doi: 10.1001/jamasurg.2021.2373.

    PubMed 34160577

  • Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.

    PubMed 26254683

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab tirumotecan and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Hebei Medical University Fourth Hospital 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 16 inclusion and 27 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 16 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 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 Zhenhua Li (+86 185 3111 5825), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic complete response (pCR) rate (time frame: Approximately 3 months after the first dose (after completion of neoadjuvant therapy and radical surgery)). 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 NCT07823270, 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 16 Sep 2026.

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