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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PFS
Timeframe: Up to 24 months
Trial details
NCT IDNCT07128693
SponsorThe First Affiliated Hospital of Zhengzhou University
. 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.
. 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.