Diffuse Large B-cell Lymphoma (DLBCL)
Conditions
Interventions
Experimental group:Hypofractionated radiotherapy followed by 4 cycles R-GEMOX+PD1 monoclonal antibody
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diffuse large B-cell lymphoma (DLBCL-NOS) was histologically confirmed; 2. No gender limit, aged 18-75 years; 3. The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2; 4. Subjects must be subjects who have not achieved CR after first-line R-CHOP 4-6 cycles of chemotherapy (refractory to treatment); 5. Evaluable lesions in PET/CT; 6. Life expectancy >=12 weeks; 7. Agree to perform PET/CT evaluation before and after salvage treatment; 8. All screening period laboratory tests are required by the programme and need to be conducted within 14 days prior to inclusion. The values of laboratory tests performed by screening must meet the following criteria: (1) All routine blood tests met the following criteria (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) : Hb>=90g/L; ANC>=1.5x10^9/L; PLT>=70x10^9/L; (2) Biochemical examination all met the following criteria: TBIL =45 mL/min (Cockcroft-Gault formula); (3) Coagulation function (unless subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) at screening are within the range expected with anticoagulant therapy) : INR <=1.5xULN; Activated partial thromboplastin time (APTT) <=1.5xULN; 9. Women with a potential for pregnancy must have a negative serum pregnancy test within 7 days before the first dose and be willing to use a highly effective method for the duration of the trial and for 120 days after the last dose of the trial drug. Male subjects with a partner of a woman of reproductive age should be surgically sterilized or consent to a highly effective method of contraception during the trial period and 120 days after the last test drug administration; 10. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Known central nervous system (CNS) aggression; 2. Known bone marrow invasion; 3. Medical history and complications: (1) Subject has any active, known, or suspected autoimmune disease. Subjects who were in stable condition and did not require systemic immunosuppressive therapy were allowed to be enrolled; (2) Subjects requiring systemic therapy with corticosteroids (> 10 mg/ day of prednisone or equivalent) or other immunosuppressant within 14 days prior to study drug administration. In the absence of active autoimmune disease, inhaled or topical steroid use and adrenal hormone replacement at doses > 10 mg/ day of prednisone efficacy dose are permitted; (3) Anti-tumor vaccine or other anti-tumor therapy with immune stimulation has been used within 3 months before the study drug is given; (4) Previous treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-ctLA-4 antibodies (or any other antibodies acting on the T-cell co-stimulation or checkpoint pathway); (5) Subjects are participating in other clinical studies or less than 4 weeks after the end of the previous clinical study; (6) Subjects with known or highly suspected history of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; (7) History of other malignant tumors; Except in subjects who have had potentially curable therapy and have not had disease recurrence for 5 years since treatment began; (8) Prior radiotherapy, immunotherapy, etc.; (9) For subjects with major surgery or severe trauma, the effects of surgery or trauma had been resolved less than 14 days before enrollment; (10) Subjects with active tuberculosis should be excluded; (11) Severe acute or chronic infections requiring systemic treatment; (12) Obvious blood coughing or daily hemoptysis of half a teaspoon (2.5ml) or more in the 2 months before randomization; (13) Had clinically significant bleeding symptoms or definite bleeding tendency within 3 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, or vasculitis; (14) Arterial/venous thrombosis events occurred within 6 months before randomization, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, pulmonary embolism, etc. (15) Hereditary or known existence. Acquired bleeding and thrombotic tendencies (e.g., hemophiliacs, coagulation disorders, thrombocytopenia, hyperplenism, etc.); (16) Have hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg); (17) Subjects with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction in the 6 months prior to screening despite receiving appropriate medication; (18) Live vaccination within 4 weeks prior to administration of the study drug. Inactivated virus vaccine administered injectable for seasonal influenza is allowed, but live attenuated influenza vaccine administered intranasally is not allowed; 4. Physical examination and laboratory examination revealed: (1) A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); (2) Untreated active hepatitis (hepatitis B: HBsAg pos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Countries
China
Contacts
Public ContactXu Benhua
Fujian Medical University Union Hospital
Outcome results
None listed