Recurrent or metastatic solid tumor
Conditions
Interventions
Combined therapy group:Radiotherapy + immune adjuvant (RO) + PD-1 mAb
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years, both genders are acceptable; 2. ECOG score 0-2 points; 3. Pathologically confirmed recurrent or metastatic solid tumors (including but not limited to pancreatic cancer, colorectal cancer, lung cancer, liver cancer, cholangiocarcinoma, gastrointestinal stromal tumor, lymphoma, head and neck tumor, gastric cancer, bone and soft tissue sarcoma, neuroendocrine tumor, etc.), disease progression despite standard treatment, or refusal/intolerance to standard treatment or lack of effective standard treatment; 4. According to the Response Evaluation Criteria for Solid Tumors (RECIST1.1), there must be one or more measurable lesions; for patients with brain metastases, there must be at least one metastatic lesion outside the brain; at least one lesion suitable for >= 5Gy/f radiotherapy and intratumoral injection (determined by the investigator whether it is suitable for radiotherapy and intratumoral injection); 5. Expected survival period >= 12 weeks; 6. The main organ functions and bone marrow function are normal, and the following requirements are met: (1) Hemoglobin 80g/L (no blood transfusion within 14 days); (2) Absolute neutrophil count >=1.5x10^9/L; (3) Platelet count >= 90 x 10^9/L; (4) Total bilirubin = 50%; (8) International normalized ratio (INR) of prothrombin time (INR) <= 1.5 and partial thromboplastin time (APTT) <= 1.5 times ULN in patients who have not received anticoagulation therapy. Patients receiving full or parenteral anticoagulant therapy as long as the anticoagulant dose is stable for at least 2 weeks before entering the clinical study, and the results of the coagulation test are within the limits of local treatment; (9) If any form of drug-induced anti-tumor therapy, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, has been performed before enrollment, patients receiving radiotherapy need to be washed out for 1 cycle or more, and patients receiving drug therapy need to be washed out for more than 5 half-lives; (10) Women of childbearing age must have a negative pregnancy test (serum or urine) result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last administration of the study drug; for males, it should be surgical sterilization or agree to use an appropriate method of contraception during the observation period and within 3 months after the last administration of the study drug; (11) The toxicity of the previous treatment has recovered to <= grade 1 (if surgery, the wound has completely healed); (12) Patients voluntarily participate and sign the informed consent form, and it is expected that the compliance will be good and can be matched according to the program requirements.
Exclusion criteria
Exclusion criteria: 1. Major surgery (except for outpatient minor surgery, such as placement of vascular access) within 4 weeks prior to enrollment; surgical fixation of the bone lesions to be irradiated is required, and mechanical stabilization is indicated; 2. Even after drug treatment, hypertension is still not well controlled (continuous increase in systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 3. Suffering from uncontrolled cardiac clinical symptoms or diseases, including: (1) NYHA II and above heart failure; (2) Unstable angina; (3) Myocardial infarction within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 4. Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (may be included after hormone replacement therapy)); patients with complete remission of childhood asthma without any intervention or vitiligo as adults, but not patients requiring medical intervention with bronchodilators; 5. Suffering from congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (positive for hepatitis C antibody and HCV-RNA above the detection limit of the analytical method) or co-infection of hepatitis B and C; 6. Complicated with severe infection within 4 weeks before the first dose (such as: need for intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5 degree C during the screening period/before the first dose; 7. Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, occurred within 6 months before enrollment; 8. Those who are known to be allergic to any test drug; 9. Pregnant, lactating patients, and patients with reproductive capacity are unwilling to take effective contraceptive measures; 10. History of clear neurological or psychiatric disorders, including epilepsy and dementia; 11. Known uncontrolled or symptomatic active central nervous system (CNS) metastases manifested by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and/or progressive growth; 12. Other situations deemed inappropriate by the researchers for inclusion. Including but not limited to family or social factors, which will affect the safety of subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate(DCR);progression-free survival(PFS); time to progression(TTP);overall survival time(OS);clinical benefit rate(CBR); | — |
Countries
China
Contacts
Public ContactLiu Baorui
Nanjing Drum Tower Hospital
Outcome results
None listed