esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Fluzoparib + Seggio combined with radiotherapy
Sponsors
Suzhou Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Gender is not limited, aged 18 to 85 years; 3. Subjects with unresectable locally advanced esophageal squamous cell carcinoma who have not received systemic or local therapy as determined by histology or cytology, including unresectable or surgical contraindications or subjects who refuse surgery; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST version 1.1), at least one lesion with measurable imaging findings; 5. ECOG score 0-1 points; 6. Expected survival time > 6 months; 7. Sufficient organ function, subjects should meet the following laboratory indicators: (1) The absolute value of neutrophils (ANC) is >= 1.5 x 10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days. (2) Platelets >= 100 x 10^9/L without blood transfusion in the past 14 days. (3) Hemoglobin >= 9 g/dL (90 g/L) or >= 5.6 mmol/L without blood transfusion or erythropoietin in the past 14 days; (4) Total bilirubin 1.5 x ULN but direct bilirubin = 60 ml/min. 8. Good blood coagulation function; 9. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; 10. Myocardial enzyme spectrum is within the normal range (if the researcher comprehensively judges that simple laboratory abnormalities that do not have clinical significance are also allowed to be included in the group); 11. For female subjects of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1). If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Females of non-reproductive age are defined as postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; if there is a risk of conception, all subjects (females) are required to stay during the entire treatment period until 120 days after the last dose of study drug Use contraception with an annual failure rate of less than 1% (or 180 days after the last chemotherapy drug dose).
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with unresectable locally advanced esophageal squamous cell carcinoma other than malignant tumors within 5 years before the first administration and uncured subjects (excluding radically cured skin basal cell carcinoma, skin squamous epithelial carcinoma, and/or Radically resected carcinoma in situ); 2. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 3. Major surgical operation within 4 weeks before enrollment; 4. Known allergy to the active ingredients or excipients of the study drug Fluzoparib and Sigirone; 5. Have not recovered sufficiently from toxicity and/or complications caused by any intervention (ie, = 2; 11. Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, has occurred within 6 months before the treatment; 12. Unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); 13. There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease; 14. Active pulmonary tuberculosis; 15. There is an active or uncontrolled infection that requires systemic treatment; 16. Clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; 17. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 18. Urine routine indicates urine protein >= ++, and 24-hour urine protein quantification > 1.0 g; 19. Subjects with mental disorders and unable to cooperate with treatment; 20. Subjects who need to use strong CYP3A4 inhibitors, moderate inhibitors and strong inducers, moderate inducers, and subjects who need to use antiviral drugs solivudine or brivudine; 21. Medical his
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate;progression-free survival; | — |
Countries
China
Contacts
Public ContactWu Jinchang
Suzhou Municipal Hospital
Outcome results
None listed