solid tumors
Conditions
Interventions
Experimental group:Carrelizumab combined with cryoablation
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with malignant solid tumors diagnosed by histopathology; 2. Aged 18 to 75 years; 3. The clinical stage is iiib, iv or patients with recurrence after surgery; 4. Have received at least first-line single-agent/combined chemotherapy in the past, and the imaging evaluation has failed or the disease has progressed; 5. EGFR, ALK, HER-2 and other sensitive genes are negative; 6. The ECOG score is 0-1 points; 7. Estimated survival period >= 3 months; 8. There must be >= 1 solid mass that meets the following criteria: At least one mass can be treated with cryotherapy for 2 courses and the risk of treatment is relatively low; At least 1 mass (the largest/continuously locally advanced mass) can benefit from cryoablation; the optimal tumor size is >1.0 cm; if cryotherapy can cover thoroughly and is safe, the maximum diameter can be considered Lumps up to 6 cm; 9. In addition to ablation lesions, there is at least one measurable lesion (according to the RECIST 1.1 standard, the CT scan length of tumor lesions is >=10mm, and the CT scan diameter of lymph node lesions is >=10mm); 10. The subject has recovered from the damage caused by other treatments, including other cytotoxic drugs, radiotherapy or surgery for >= 4 weeks, and the wound has healed completely; 11. The subject should have never received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 12. Asymptomatic brain metastasis or focus control after brain metastasis radiotherapy; 13. Routine laboratory tests (blood routine, liver and kidney function, coagulation function, etc.) have no significant abnormalities: (1) Routine blood examination standards must meet (no blood transfusion and blood products within 14 days): 1) ANC>=1.5x10^9/L; 2) PLT>=80x10^9/L; (2) The biochemical inspection shall meet the following standards: 1) TBIL 45 ml/min (Cockcroft-Gault formula); (3) The coagulation function must meet the following standards: International Normalized Ratio (INR) <= 1.5xULN, and activated partial thromboplastin time (APTT) <= 1.5 x ULN; (For patients receiving anticoagulation therapy, such as taking anticoagulation Drugs such as aspirin, warfarin, clopidogrel, etc., in principle, need to be stopped for at least 5-7 days, and the investigator judges that both INR and APTT are within the safe and effective treatment range). 14. Provide enough tissue samples for PD-L1 or TMB tests or blood samples (1 week before treatment, 1 week after ablation, immune evaluation once every two months) for follow-up analysis; 15. Patients with potential for childbirth need to use a medically approved contraceptive method (such as intrauterine device, contraceptive or condom) during the study treatment period and within 1 month after the end of the study treatment period; and The serum or urine HCG test must be negative within 72 hours before enrollment in the study, and it must be a non-lactating period; 16. The subjects voluntarily joined the study and signed an informed consent form, with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously allergic to any component of the test drug: Camrelizumabb; 2. The subject's refractory pleural or pericardial effusion is poorly controlled; 3. Previously received anti-PD-1 or PD-L1 or CTLA-4 or Car-T immunotherapy; 4. A history of interstitial lung disease (except for radiation pneumonia not treated with national hormones) and a history of non-infectious pneumonia; 5. The subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis , Nephritis, hyperthyroidism, decreased thyroid function; subjects suffering from vitiligo or asthma in childhood has been completely relieved, and can be included if they do not require any intervention after adulthood; subjects that require bronchodilators for medical intervention can not be included ); 6. The subject is using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other curative hormones), and within 2 weeks before enrollment Still in use; 7. Severe infections (CTCAE > level 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization, etc.; baseline chest imaging examinations suggest the presence of active lung inflammation, Symptoms and signs of infection or the need for oral and intravenous antibiotic treatment 2 weeks before the first use of the study drug, except for the prophylactic use of antibiotics; 8. The subject has experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. within one month, and the cardiovascular clinical symptoms or diseases have not been well controlled; 9. According to NYHA standards, grade iii to iv cardiac insufficiency, or cardiac color Doppler ultrasound examination reveals that the left ventricular ejection fraction (LVEF) is less than 50%; 10. Patients with a clear gastrointestinal bleeding tendency, including the following conditions: local active ulcer lesions, and fecal occult blood {(++)can not be included in the group}; patients with a history of melena and hematemesis within 2 months; 11. Abnormal blood coagulation function (INR > 1.5 APTT > 1.5 ULN), with bleeding tendency; 12. Long-term unhealed wounds or fractures; major surgical operations or severe traumatic injuries, fractures or ulcers occurred within 4 weeks; 13. Subjects with congenital or acquired immune deficiencies (such as HIV-infected persons), or active hepatitis (hepatitis B reference: HBV DNA test value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA test value exceeds the upper limit of normal value ); 14. People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 15. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 16. The investigator believes that it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Remission maintenance time;Overall survival;Disease control rate;Quality of Life; | — |
Countries
China
Contacts
Public ContactSong Wei
Shandong Provincial Hospital
Outcome results
None listed