Recurrent or metastatic solid tumor
Conditions
Interventions
Combined therapy group:Radiotherapy / R + intratumoral injection of FOLactis + PD1
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 80 years old, regardless of gender; 2. Subjects with ECOG score of 0-2; 3. The patients with recurrent or metastatic solid tumors were confirmed by pathology (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 still occurs under standard treatment, or rejection / intolerance of standard treatment or lack of effective standard treatment; 4. According to the solid tumor remission evaluation criteria (RECIST1.1), there is one or more measurable lesions; for patients with brain metastasis, at least one metastasis is required; at least one focus is suitable for >= 5Gy/f radiotherapy and intratumoral injection (determined by the researchers whether it is suitable for radiotherapy and intratumoral injection); 5. Expected survival time 12 weeks; 6. Subjects with the main organ function and bone marrow function are normal, meeting the following requirements: (1) Hemoglobin >=90g/L(no blood transfusion within 14 days); (2) Neutrophils>=1.5 × 10^9/L; (3) Platelet>= 90 × 10^9/L; (4) Total bilirubin = 50%; (8) The international standardized ratio (INR) of prothrombin time (INR) and partial thromboplastin time (APTT) <= 1.5 times ULN in patients who had not received anticoagulant therapy. Patients who receive full or parenteral anticoagulant therapy as long as the dose of anticoagulant is stable for at least 2 weeks before entering the clinical study, and the results of coagulation test are within the limits of local treatment; (9) If patients have received any form of drug anti-tumor therapy, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, patients receiving radiotherapy need to be eluted for 1 cycle or more, and patients receiving drug therapy need to be eluted for more than 5 half-lives; (10) Women of childbearing age should undergo pregnancy test (serum or urine) negative within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period and within 3 months after the last study drug administration; for men, they should be sterilized or agree to use appropriate methods of contraception during the observation period and within 3 months after the last study drug administration;(11) Subjects with the toxicity of pre-treatment has recovered to <= 1 (if there is an operation, the wound has been completely healed); (12) Patient voluntarily participated and signed the informed consent form, which is expected to have good compliance and can be matched according to the requirements of the scheme.
Exclusion criteria
Exclusion criteria: 1. Major operations were performed within 4 weeks before enrollment (except minor outpatient surgery, such as placement of vascular access); surgical fixation of bone lesions to be irradiated was needed, and mechanical stability was pointed out; 2. Even after drug treatment, hypertension was not controlled satisfactorily (continuous increase of systolic blood pressure >= 150mmHg or diastolic blood pressure >= 100mmHg) 3. Patients with uncontrolled heart symptoms or diseases, including: (1) heart failure with NYHAII or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 4. Patients with any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (which can be included after hormone replacement therapy). Patients with childhood asthma have been completely relieved and can be included in adults without any intervention or vitiligo, but not in patients who need bronchodilators for medical intervention; 5. Patients who suffer from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500IU/ml), hepatitis C (hepatitis C antibody positive, and HCV-RNA is higher than the lower limit of detection by analytical method) or co-infection of hepatitis B and hepatitis C. 6. Patients who severe infection within 4 weeks before first administration (e.g. intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever > 38.5?; 7. Patients with arteriovenous thrombosis events occurred within 6 months before admission, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism, etc. 8. Patients who are known to be allergic to any experimental drug; 9. Pregnant and lactating women.Patients with reproductive ability are not willing to take effective contraceptive measures; 10. Patients who have a clear history of neurological or mental disorders, including epilepsy and dementia. 11. Patients with known uncontrollable or symptomatic active central nervous system (CNS) metastasis, characterized by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth. Other conditions that the researchers believe are not suitable for inclusion. Including and not limited to family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control rate(DCR);progression-free survival(PFS);time to progression(TTP);overall survival time(OS);clinical benefit rate(CBR);objective response rate (ORR); | — |
Countries
China
Contacts
Public ContactRutian Li
Outcome results
None listed