a multi-center, non-randomized, open-label phase ii clinical study on the treatment of newly diagnosed advanced hodgkin's lymphoma with pd-1 antibody (tislelizumab) combined with avd regimen (doxorubicin, vindesine, dacarbazine) under the guidance of pet/ct

Conditions: Hodgkin Lymphoma; Chemotherapy Effect

Summary: the experimental drug regimen in this study includes a pd-1 antibody (tislelizumab) single-drug induction treatment period and a pd-1 antibody + avd combined treatment period. 1. pd-1 antibody (tislelizumab) single-drug induction treatment period (first 2 courses for all patients + 3-6 courses for cr patients): pd-1 antibody (tislelizumab), specification: 100mg/bottle. usage and dosage: intravenous drip, 200mg each time, qd, d1. in the above pd-1 antibody single-drug regimen, 21 days are regarded as a treatment cycle, and all patients first receive 2 courses of pd-1 antibody single-drug induction treatment; 2. pet/ct mid-term efficacy evaluation used for guiding follow-up treatment options: pet/ct efficacy evaluation before the 3rd course of treatment (pet/ct2): cr patients: continue to receive pd-1 antibody monotherapy, and then receive 4 courses of pd-1 antibody therapy; pr patients: sequential 4 courses of pd-1 antibody + avd combined chemotherapy; pd+sd patients: out group, and receive other anti-lymphoma therapy deemed suitable by the investigators; after the 6th course, patients not out of the group receive pet/ct3 efficacy evaluation: cr patients: end the treatment and enter the follow-up; pr patients: receive 2 more courses of pd-1 antibody + avd combined chemotherapy, and then enter the follow-up. 3. pd-1 antibody + avd combined treatment period (3rd-6th/8th course for pr patients): pd-1 antibody, specification: 100mg/bottle. usage and dosage: intravenous drip, 100mg each time, qd, d1, d15. avd regimen doxorubicin 25mg/m2, d1, d15 intravenous injection vindesine 3mg/m2, d1, d15 intravenous injection dacarbazine 0.375mg/m2, d1, d15 intravenous drip in this combined treatment regimen, every 28 days is a treatment cycle, and the pd-1 antibody is used in combination with avd in d1 and d15 of each treatment cycle.


Eligibility criteria:
inclusion criteria: 1. patients with newly diagnosed classical hodgkin lymphoma (hl) confirmed by histopathology; 2. stage iii-iv, or stage iib patients with at least one high-risk factor (nccn standard) 3. patients not suitable for receiving radiotherapy subsequently 4. patients with at least one assessable lesion (according to lugano 2014 standard); 5. age 18 or above (including 18), no gender requirement; 6. ecog ps score of 0-1 points; 7. expected survival time ≥ 3 months; 8. hematopoietic function: absolute neutrophil count ≥ 1.5×109/l, platelets ≥ 90×109/l, hemoglobin ≥ 90g/l; liver function: for patients with non-hepatitis b, total bilirubin, alt and ast \<1.5×uln (upper limit of normal); patients with hepatitis b need to take effective antiviral drugs, and hbv-dna copy \<2000 iu/ml and alt\<2×uln; renal function: creatinine \<1.5×uln and creatinine clearance rate ≥50ml/min; 9. with normal main indicators of cardio-pulmonary function, and no obvious contraindication to chemotherapy; 10. not received any anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, cellular immunotherapy or hematopoietic stem cell transplantation before enrollment; 11. voluntarily signing an informed consent form before trial screening. exclusion criteria: 1. nodular lymphocyte predominant hl; 2. patients received any form of anti-tumor therapy in the past; 3. patients planning to receive radiotherapy or autologous stem cell transplantation; 4. with involvement of central nervous system (meninges or brain parenchyma); 5. pregnant and lactating women and child-bearing patients who are unwilling to take contraceptive measures; 6. patients with history of other tumors, except for cured cervical cancer orskin basal cell carcinoma; patients who have received organ transplantation; 7. patients who have received symptomatic treatment of myelosuppressive toxicity within 7 days before enrollment; 8. patients who have used any immunosuppressive drugs within 4 weeks before the first-dose treatment, 9. patients with known active interstitial pneumonia; 10. abnormal liver function (total bilirubin\>1.5×uln, alt/ast\>2.5×uln or alt/ast\>5×uln for patients with liver invasion), abnormal renal function (serum creatinine\>1.5×uln), abnormal electrolyte metabolism; 11. peripheral neuropathy ≥ grade 2; 12. patients with a history of prolonged qt interval which is of clinical significance (male\> 450ms, female\> 470ms), ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi) within 1 year, congestive heart failure (chf), patients with symptomatic coronary heart disease requiring drug therapy; 13. patients with the end-diastolic width of fluid sonolucent area in pericardial cavity ≥10mm by cardiac b-ultrasonography; 14. mentally disturbed/patients unable to give informed consent; 15. patients who affect the evaluation of test results due to drug abuse or long-term alcohol abuse; 16. participating in another interventional clinical study at the same time; patients not suitable to participate in this trial by the judgment of investigators.