esophageal squamous cell carcinoma
Conditions
Interventions
Group 1 :Nilaparib: 200 mg oral QD from the day of initiation of radiotherapy to the day after completion of radiotherapy
Radiotherapy: At least 1 tumor suitable for biopsy was selected to undergo SBRT, 4-8 Gy/day, 3-5 times in total
(During the maintenance phase of immunotherapy and within 8 weeks after compl
Sponsors
Shandong Cancer Hospital Affiliated to Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects understand the trial process, voluntarily sign the informed consent form, and agree to participate in the research; 2. Age 18-75 (inclusive), gender is not limited; 3. Esophageal squamous cell carcinoma confirmed by histology or cytology; 4. Pathological stage: any TN3M0 or any T any NM1; 5. According to RECIST1.1 standard, there are >= 2 target lesions that can be assessed and measured; 6. Previous treatment with anti-PD-L1 antibodies is allowed; 7. Expected survival period >= 3 months; 8. Accept the standard treatment plan chosen by the doctor and evaluate as PR/SD; 9. ECOG physical status score is 0-1; 10. Agree to collect blood samples and tumor tissue samples for subsequent pathological biopsy analysis; 11. Good organ function, including: (1) Neutrophil count >= 1.5 x 10^9/L; (2) Platelets >= 100 x 10^9/L; (3) Hemoglobin >= 100 g/L; (4) Serum creatinine = 60 mL/min (calculated according to the Cockcroft-Gault formula); (5) Total bilirubin = 50%; 12. Serum or urine pregnancy test results of female subjects of childbearing age were negative when they enrolled. Enrolled women of childbearing age and men with partners of childbearing potential must commit to taking adequate and effective contraceptive measures or abstinence from the beginning of the study to the end of the study and within 6 months after the last administration of the study drug. Or the women enrolled in this study are women without potential fertility, defined as: women who have undergone surgical fertility surgery (hysterectomy, bilateral oophorectomy or bilateral salpingectomy), or women >= 60 years old, or >=40 and < 60 years old, menopause for more than 12 months; 13. Agree to do relevant inspections and have the ability to comply with the plan.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to niraparib or active or inactive ingredients of drugs with a similar chemical structure to niraparib; 2. People who are known to be allergic to PD-(L)1 or active or inactive ingredients of drugs with similar chemical structures to PD-(L)1; 3. Received chemotherapy or major surgery within 3 weeks before the start of the study, or any surgical effects that have not recovered after surgery; 4. The target lesion has received radiation therapy within 4 weeks before starting to use the study drug; palliative radiation therapy of > 20% bone marrow has been received 1 week before enrollment; 5. Patients with other malignant tumors other than esophageal squamous cell carcinoma within 5 years before enrollment (except cervical cancer in situ, basal cell carcinoma, and superficial bladder tumors that have been radically treated); 6. Previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML); 7. Suffering from serious or uncontrolled diseases, including but not limited to: (1) Uncontrollable nausea and vomiting, inability to swallow the study drug, any gastrointestinal diseases that may interfere with drug absorption and metabolism; (2) Active viral infection such as human immunodeficiency virus (HIV antibody positive), hepatitis B HBV (HbsAg positive, and HBV-DNA >= 103 copy number/ml or >= 500 IU/ml), hepatitis C (anti-HCV positive and/or HCVRNA positive and combined with clinical judgment), etc.; (3) Uncontrolled grand mal seizures, unstable spinal cord compression, superior vena cava syndrome or other mental disorders that affect the subject's signing of informed consent; (4) Immunodeficiency (except splenectomy), or other diseases that the researchers believe may expose the subject to high-risk toxicity; 8. The need to use any class of corticosteroids for systemic treatment ( > 10 mg/day prednisone) or other immunosuppressive drugs within 14 days of the study medication; in the absence of active autoimmune diseases, inhalation or Topical steroids and adrenal replacement doses ( <= 10 mg/day prednisone); patients are allowed to use topical, intraocular, intra-articular, intranasal, and inhaled corticosteroids (less systemic absorption); physiological replacement doses of systemic corticosteroids are allowed ( <= 10 mg/day prednisone); short-term corticosteroid therapy for prevention (such as contrast medium allergy) or treatment of non-autoimmune diseases (such as delayed hypersensitivity caused by contact allergens) is allowed; 9. Bleeding tendency and history of thrombosis: (1) Any bleeding events of CTCAE 5.02 grade within 3 months before screening, or bleeding events of CTCAE 5.03 grade and above within 6 months before screening; (2) Have a history of gastrointestinal bleeding within 6 months before screening or have a clear tendency to gastrointestinal bleeding. Such as: esophageal varices with bleeding risk, local active ulcer lesions, or more than occult blood in stool; (3) Active bleeding or abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy; (4) Subjects need anticoagulant therapy with drugs such as warfarin or heparin; (5) Subjects need long-term antiplatelet therapy (such as aspirin, clopidogrel); (6) Thrombosis or embolism events occurred within the past 6 months, such as: cerebrovascular accident (including transient ischemic attack), pulmonary embolism; 10. History of severe cardiovascu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rate;Incidence of serious adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Duration of remission, DOR; | — |
Countries
China
Contacts
Public ContactBaosheng Li
Shandong Cancer Hospital Affiliated to Shandong University
Outcome results
None listed