KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer

Summary

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).

Eligibility

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.

Conditions2

Interventions4

Browse More Trials