Sacituzumab Govitecan Combined With Tislelizumab for Locally Advanced/Metastatic Esophageal Cancer

NCT07811752 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ShanghaiChest ESO
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators.

  Up to 24 months

Secondary Outcomes (5)

• PFS

  Up to 24 months

• DCR

  Up to 24 months

• DOR

  Up to 24 months

• OS

  Up to 24 months

• Adverse Events (AEs)

  Up to 24 months

Study Arms (1)

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.

Drug: Sacituzumab Tirumotecan (SKB264) plus Tislelizumab

Interventions

Sacituzumab Tirumotecan (SKB264) plus Tislelizumab DRUG

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.

Sacituzumab Tirumotecan in combination with tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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:
• )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.
• 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.
• Known hypersensitivity to any study drug or any of its excipients.
• Positive test for human immunodeficiency virus (HIV), history of acquired immunodeficiency syndrome (AIDS), or known active syphilis infection.
• 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.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Receipt of a live vaccine within 30 days prior to the first dose of study treatment.
• 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.
• 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.
• Active infection requiring systemic therapy within 2 weeks prior to the first study dose.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (2)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 39711430 BACKGROUND

• Xu 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.

  PMID: 37080222 BACKGROUND

• Xiong 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.

  PMID: 42214392 BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Jun Liu

CONTACT

+86-21-2220000; drjunliuplus@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate senior doctor

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)