cHL
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient with histologically proven relapsed or refractory classical Hodgkin lymphoma; 2. ECOG 0-2; 3. No prior systemic anticancer therapy; 4. There is at least one imaging measurable lesion; 5. Able to understand the purpose and risks of the study and provide signed and dated informed consent form; 6. With a minimum life expectancy of 3 months.
Exclusion criteria
Exclusion criteria: 1. Known nodular lymphoma predominant Hodgkin lymphoma 2. History and complication as follows: 1) Active autoimmune disease; 2) Prior exposure to any PD-1/PD-L1/PD -L 2 or CTLA -4 antibody; 3) Participating in other clinical studies or less than 4 weeks before the end of a clinical trial; 4) Received anti-tumor vaccines or other anti-tumor therapy with immune stimulation within 3 months; 5) Known interstitial pneumonia; 6) Other active malignancies that required treating; 7) Received chemotherapy, radiotherapy,immunotherapy, including topical therapy within 4 weeks; 8) Severe acute or chronic infection requiring systemic therapy; 9) Suffering from heart failure (New York Heart Association standard III or IV). Uncontrolled coronary artery disease and arrhythmia although given appropriate medical treatment. History of myocardial infarction within 6 months; 3. Laboratory test: 1) Known HIV positive or known AIDS; 2) Untreated active hepatitis: Hepatitis B and hepatitis C; 4. Other factors that may lead to the study termination, such as severe disease or abnormal laboratory tests or family or social factors affecting subjects safety or test data and sample collection; 5. Pregnant or lactating women; 6. known allergy to the ingredients of the test drug; 7. with other malignant tumors requiring treatment; 8. patients that researchers believe that it is not suitable for them to join the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best CRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| rate of ORR;the rate of PFS at sixth month; | — |
Countries
China
Contacts
Anhui Provincial Cancer Hospital