💬In plain words
What the trial is, and whether it could suit you
The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Males or females aged 18 to 75 years;
* Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;
* Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease;
* At least one measurable tumor lesion according to RECIST 1.1;
* Eastern Cooperative Oncology Group performance status score of 0 or 1;
* Life expectancy \> 12 weeks;
* BMI≥16.0 kg/m2;
* Adequate bone marrow, renal, and hepatic function;
* Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before the first dose;
* Patients should participate in the study voluntarily and sign informed consent.
Exclusion Criteria:
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis;
* Other malignancies within the past 5 years;
* Known hypersensitivity to any monoclonal antibodies or chemotherapy components;
* Gastrointestinal abnormalities;
* High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal/tracheal fistula;
* Cardiovascular and cerebrovascular diseases;
* Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment;
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;
* Active autoimmune disease or a history of autoimmune disease requiring systemic treatment;
* Active infections, including severe infection (CTCAE \> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV;
* Pregnant or lactating women;
* Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study;
* Other conditions assessed by the investigator that would increase safety risks or interfere with the study results.
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