Esophageal cancer
Conditions
Interventions
Experimental Group:Surufatinib combined with albumin - bound paclitaxel and toripalimab
Sponsors
Department of Radiation Oncology, the First Medical Center, Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Over 18 years old; 2. Locally advanced or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology; 3. Has not received systemic treatment for locally advanced or metastatic esophageal squamous cell carcinoma in the past; 4. Clearly indicate that there are measurable lesions that meet the requirements of RECIST (1.1); 5. Liver function: Child-Pugh grade A (5-6 points) or relatively good grade B (= 4.0 x 10^9/L, neutrophils >= 1.5 x 10^9/L, platelets >=100 x 10^9/L, hemoglobin >= 90g/L; b) The international normalized ratio (INR) is less than or equal to 1.5× upper limit of normal (ULN), and the activated partial thromboplastin time (APTT) is less than or equal to 1.5×ULN; c) Liver function: Total bilirubin = 50%. 10. Fully understand this research, voluntarily participate, and sign the informed consent form. 11. Male or female patients with fertility voluntarily used effective contraceptive methods during the study period and within 6 months of the last study medication.
Exclusion criteria
Exclusion criteria: 1.Patients with stage T4 esophageal squamous cell carcinoma; 2. Patients who have previously received anti-VEGF/VEGFR-targeted drug therapy and have experienced disease progression during the treatment period; 3. Has previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1; 4. Have participated in other domestic drug clinical trials that have not been approved or marketed within 4 weeks prior to enrollment and received treatment with the corresponding trial drugs; 5. Had any surgery or invasive treatment or operation (except for intravenous catheterization, puncture and drainage, etc.) been received within 4 weeks prior to the start of enrollment; 6. The patient currently has hypertension that cannot be controlled by medication, which is defined as: systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg; 7. The patient currently has any diseases or conditions that affect drug absorption, or the patient is unable to take suversitinib orally; 8. The patient currently has active ulcers in the stomach and duodenum, ulcerative colitis or other digestive tract diseases, or the unresected tumor has active bleeding, or other conditions that the researcher determines may cause digestive tract bleeding or perforation; 9. Patients with obvious evidence or history of bleeding tendency within 3 months before enrollment (bleeding >30 mL within 3 months, with hematemesis, melena, or hematochezia), hemoptysis (more than 5 mL of fresh blood within 4 weeks), or those who have experienced thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 10. Those whose urine routine test indicates urine protein >=2+ and whose 24-hour urine protein content is greater than 1.0g; 11. Had taken drugs containing Forsythia suspensa components within 3 weeks before enrollment, or had taken other strong inducers or strong inhibitors of CYP3A4 within 2 weeks before enrollment; 12. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to enrollment; Congestive heart failure with New York Heart Association (NYHA) grade >2; Ventricular arrhythmias requiring drug treatment; The electrocardiogram (ECG) examination shows that the QTc interval is >=480 milliseconds. 13. Suffering from any active autoimmune disease or having a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy returns to normal); 14. Patients with vitiligo or those whose childhood asthma has been completely relieved and do not require any intervention in adulthood can be included. However, asthma patients who need medical intervention with bronchodilators cannot be included. 15. There is a known history or evidence of interstitial lung disease or active non-infectious pneumonia; 16. Suffering from congenital or acquired immune deficiency (such as HIV-infected individuals), active hepatitis B (HBV-DNA>=104 copies /ml), or hepatitis C (positive hepatitis C antibody, and HCR-RNA higher than the detection limit of the analytical method); 17. Known to be allergic to paclitaxel, macromolecular protein preparations, or any anti-PD-1 antibody component; 18. Subjects who were required to recei
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactFang Liu
Department of Radiation Oncology, the First Medical Center, Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed