Malignant solid tumors
Conditions
Interventions
Experimental group:First radiotherapy: lattice radiotherapy, apex dose 8-16 Gy, peripheral dose 3 Gy
Follow-up conventional palliative radiotherapy >=40 Gy
PD-1/PD-L1 monoclonal antibody-based regimen: PD-1/PD-L1 monoclonal antibody conventional dose in combination with other investigator's choice regimen
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Be over 18 years old (including 18 years old); 2. Solid tumors confirmed by histology or cytology and assessed by oncologists to have indications for palliative radiotherapy (target lesions with a diameter of > 40mm and a volume of >50cm^3, and patients with primary brain tumors and/or brain metastases at the site of radiotherapy are excluded). Circumcludes conditions that, in the opinion of the investigator, will have perforation, bleeding, and other unacceptable risks after treatment. Radiotherapy techniques are IMRT and above. 3. Estimated survival >=12 weeks; 4. Eastern Tumor Tissue Collaboration Group (ECOG) performance status score of 0 or 1; 5. The function of major organs is good, and the minimum expected survival is not less than 3 months; 6. At least 1 previously unirradiated tumor lesion can be accurately measured at baseline, with a diameter of >40 mm and a volume of >50cm^3 at baseline. The measurement method chosen is suitable for accurate repeat measurements, which can be computed tomography (CT) or magnetic resonance scanning (MRI). 7. Females of childbearing potential should take appropriate contraceptive measures and should not breastfeed from screening to 6 months after stopping study treatment. Have a negative pregnancy test prior to initiation of dosing, or demonstrate no risk of pregnancy if one of the following criteria is met: a. Postmenopausal is defined as being older than 50 years of age and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; b. Women younger than 50 years of age who are considered postmenopausal if they have been amenorrheic for 12 months or more after stopping all exogenous hormone therapy, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the laboratory reference values for postmenopausals; c. Have undergone irreversible sterilization surgery, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, with the exception of bilateral tubal ligation; 8. Male patients should use barrier contraception (i.e., condoms) from screening until 6 months after discontinuation of study treatment; 9. Tumor tissue/blood samples are available for genomic analysis; 10. I voluntarily participate and sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors (except for adequately treated non-melanoma skin cancer or lentigo maligna, effectively treated carcinoma in situ or other effectively treated solid tumors, with no signs of disease within 5 years >after the end of treatment, and according to the opinion of the treating doctor, there is no greater risk of recurrence of previous malignant tumors) and require standardized treatment or major surgery within 2 years after the first treatment of the study; 2. At the time of initiation of study treatment, there are residual toxicities from previous treatment that are greater than NCI-CTCAE grade 1 that have not been relieved, except for those with alopecia and grade 2 neurotoxicity caused by previous chemotherapy; 3. Within 7 days before the first dose, uncontrollable serous effusions requiring frequent drainage or medical intervention (such as pleural effusion, peritoneal effusion, pericardial effusion, etc.) require additional intervention within 2 weeks after the intervention (excluding exfoliative cytology testing of exudate); 4. As judged by the investigator, any serious or poorly controlled systemic disease, such as poorly controlled hypertension, active bleeding constitution, or active infection. There is no need to check for chronic diseases; 5. Match any of the following cardiac test results: a. The mean corrected QT interval (QTc) of 3 electrocardiograms (ECGs) at rest was > 470 msec, and the Fridericia formula was used to correct the QT interval (QTcF); b. Resting ECG suggests the presence of a variety of clinically significant rhythmic, conduction, or ECG morphological abnormalities (e.g., complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, and PR interval >). 250 msec); c. Presence of any factor that increases the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in an immediate family member under 40 years of age, or any concomitant medication that prolongs the QT interval; d. Functional assessment: left ventricular ejection fraction (LVEF) <50%, history of myocardial infarction, severe or unstable angina pectoris or coronary artery bypass surgery or cardiac insufficiency grade = New York Heart Association (NYHA) grade 2 in the last 6 months; 6. Known history of prior interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment; or acute onset or progressive pulmonary symptoms at baseline that are considered by the investigator to be inappropriate for enrollment or are judged to be high-risk factors for the possibility of interstitial lung disease and are not suitable for enrollment; 7. Diagnosed with immunodeficiency or active autoimmune disease (except a. controllable type I diabetes mellitus b. hypothyroidism [controlled with hormone replacement therapy alone] c. controllable celiac disease d. skin diseases that do not require systemic treatment [e.g., vitiligo, psoriasis, alopecia] e. any other disease that is not expected to recur if there is no external trigger)) 8. Grade 2 adverse reactions in the process of receiving PD-1/PD-L1 in the past, resulting in the occurrence of drug discontinuation. 9. Insufficient bone marrow reserve or organ function to meet the following laboratory limits: Absolute neutrophil count <1.5×10^9/L; b. Platelet count < 100
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation;Dose limited toxicity of Vertices for Lattice radiotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Overall survival;Duration of Response;Objective remission rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactLinlin Wang
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed