Refractory solid malignant tumor
Conditions
Interventions
experimental group:Stereotactic brachytherapy (SABT) combined with immune checkpoint inhibitor-sintilimab
Sponsors
The Affiliated Zhongshan Hospital of Dalian University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged >= 18 years and = 2 line treatment, is defined as refractory; 2) The number of metastatic lesions 3 months; 9. Sufficient organ function, subjects need to meet the following laboratory indicators: 1) The absolute value of neutrophils (ANC) >= 1.5 x 10^9/L when no granulocyte colony stimulating factor is used in the past 14 days; 2) In the case of no blood transfusion in the past 14 days, platelets >= 100 x 10^9/L; 3) In the past 14 days without blood transfusion or erythropoietin, hemoglobin > 9g/dL; 4) Total bilirubin ULN but direct bilirubin = 60 ml/min; 7) Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN; 8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; 9) Myocardial enzyme spectrum is within the normal range (if the investigator comprehensively judges that simple laboratory abnormalities are not clinically significant, they are also allowed to be included); 10. For female subjects of childbearing age, a urine or serum pregnancy test and the result should be negative within 3 days before receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-bearing age are defined as at least 1 year after menopause, or have undergone surgical sterilization or hysterectomy; 11. If there is a risk of conception, all subjects (whether male or female) must use contraceptive measures with an annual failure rate of less than 1% during the entire treatment period until 120 days after the last study drug administration.
Exclusion criteria
Exclusion criteria: 1. Have received the following therapies in the past: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or for another stimulating or synergistic inhibition of T cell receptors (for example, CTLA-4, OX-40, CD137) drug; 2. Have received the following treatments: 1) Received systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine with anti-tumor indications), etc. within 3 weeks before treatment; 2) Have received any investigational drug treatment within 4 weeks before treatment; 3) Receiving large doses of immunosuppressive drugs within 4 weeks before treatment (systemic glucocorticoids exceeding 10mg/day prednisone or its equivalent dose); 4) Received live attenuated vaccine within 4 weeks before treatment (or plan to receive live attenuated vaccine during the study period); 5) Have received major surgery within 4 weeks before treatment, or have unhealed surgical wounds, ulcers or fractures. 3. There is clinically uncontrollable pleural effusion/abdominal effusion (patients who do not need to drain the effusion or stop drainage for 3 days without a significant increase in effusion can be included); 4. Subjects who have received thoracic radiotherapy of greater than 30Gy within 6 months before treatment or palliative radiotherapy of 30Gy or less within 7 days before treatment (allowing the palliative of bone lesions or intracranial lesions) Radiation Therapy); 5. Symptomatic central nerve metastasis and/or cancerous meningitis. For asymptomatic brain metastases or patients with stable symptoms after brain metastasis treatment, they can participate in this study as long as they meet the following criteria: there are measurable lesions outside the central nervous system, without midbrain, pons, cerebellum, medulla oblongata or spinal cord Metastasis, no history of intracranial hemorrhage, no glucocorticoid treatment is currently needed; 6. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 7. Those who are known to be allergic to the active ingredients or excipients of Sintilizumab; 8. Before starting treatment, have not fully recovered from toxicity and/or complications caused by any intervention (ie, <= Grade 1 or reach baseline, excluding fatigue or hair loss); 9. Known human immunodeficiency virus (HIV) infection history (ie HIV 1/2 antibody positive); 10. Untreated active hepatitis B (defined as HBsAg positive and the number of HBV-DNA copies detected at the same time is greater than the upper limit of the normal value of the laboratory department of the research center); Note: Hepatitis B subjects who meet the following criteria can also be included in the group: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first administration, subjects should receive anti-HBV treatment during the entire study chemotherapy drug treatment period to avoid virus reactivation 2) Subjects with anti-HBc (+), HBsAg (-), anti-HBs (-) and HBV viral load (-) do not need to receive preventive anti-HBV treatment, but need to closely monitor virus reactivation 12. Active HCV infected subjects (HCV antibody-positive and HCV-RNA level is higher than the lower limit of detection); 13. Live vaccines have been vaccinated within 30 days before the first administration (cycle 1, day 1); 14. Pregnant or lactating women; 15. There are any serious or uncontrollable systemic diseases, such as: 1) The resting ele
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-free survival;Disease control rate;Overall survival; | — |
Countries
China
Contacts
Public ContactWang Ruo-Yu
The Affiliated Zhongshan Hospital of Dalian University
Outcome results
None listed