Efficacy, Safety
Conditions
Brief summary
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
Interventions
DRUGPD-L1 inhibitor
Enrolled patients received durvalumab/ Atezolizumab plus chemotherapy or target therapy treatment (durvalumab,1000mg，iv, d1, 21day as a cycle; Atezolizumab,1200mg iv, d1, 21day as a cycle.)
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form * Ability to comply with protocol * Aged ≥ 18 years * Histologically documented advanced solid tumor beyond lung cancer * Disease progression during or following at least one line treatment containing PD-1 immunotherapy. * Measurable disease, as defined by RECIST v1.1 * ECOG performance status of 0 or 1 * Life expectancy ≥ 12 weeks * Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts \> 2.5 × 109/L and \< 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion. Liver function tests meeting one of the following criteria: AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase ≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase \> 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Exclusion criteria
* Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments * Leptomeningeal disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Uncontrolled hypertension * Autoimmune disease * Had undergone a serious anaphylactic reaction in previous immunotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DCR | At the end of Cycle 3 (each cycle is 21 days). | Disease Control Rate |
| PFS | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months | overall survival |
| AE | hrough study completion, an average of 1 year | adverse event caused by the treatment |
Contacts
Primary ContactXiaochun Zhang, Prof
Outcome results
None listed