Status:
UNKNOWN
a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
Lead Sponsor:
Shanghai Pulmonary Hospital, Shanghai, China
Conditions:
Extensive Stage Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
Eligibility Criteria
Inclusion
- 18 to 75 years old
- Confirmed diagnosis of Extensive small cell lung cancer
- Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
- The function of vital organs meets the following requirements. WBC ≥ 3.0 × 10\^9/L, ANC≥1.5×10\^9/L, PLT≥100×10\^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
- have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
- The estimated survival period is more than 8 weeks
- The subjects voluntarily joined the study, signed informed consent,
Exclusion
- Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
- Leptomeningeal diseases
- Uncontrolled or symptomatic hypercalcemia
- Active, known or suspected autoimmune diseases
- have received any T cell co stimulation or immune checkpoint therapy
- Corticosteroids (\> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
- Subjects had active infections
- Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
- Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
- According to the researcher's judgment, there are other factors that may lead to the termination of the study
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT04790539
Start Date
April 1 2021
End Date
December 31 2022
Last Update
March 10 2021
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