A Single-center, Multicohort, Phase II Clinical Study Evaluating the Combination Therapy of Sacit… (NCT07128693) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
60 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. ECOG performance status score of 0 or 1.
✓. Expected survival time ≥ 12 weeks.
Exclusion criteria
✕. 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.
What they're measuring
1
PFS
Timeframe: Up to 24 months
Trial details
NCT IDNCT07128693
SponsorThe First Affiliated Hospital of Zhengzhou University
✕. 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.
✕. 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.