To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.
This is a prospective, single-arm trial. To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy. Induction Period: Participants received adebrelimab (1200 mg, iv., Day1) + carboplatin (AUC 4-5 mg/mL/min)/cisplatin (75 mg/m2) + etoposide (100 mg/m2, D1-3) for 4-6 cycles of three weeks. Maintenance phase: Participants received adebrelimab (1200mg, iv., Day1) + apatinib (250mg, po., daily) once every three weeks. Follow-up: After disease progression, at the discretion of the investigator, apatinib and adebrelimab can be used across lines: For platinum-sensitive patients (≥3 months from last chemotherapy): apatinib and adebrelimab plus platinum-containing two-agent chemotherapy (irinotecan/purple shirts in combination with platinum); for patients with PFS1 \>12 months: chemotherapy can be continued with the original EC/EP regimen; For platinum-resistant patients (\<3 months from last chemotherapy): apatinib and adebrelimab plus concurrent single-agent chemotherapy (irinotecan or single-agent purple shirts). The dose of chemotherapy agents was adjusted empirically by the investigators. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), and overall survival (OS); PFS2 (defined as time from enrolment to second disease progression or death) Our study will also explore biomarkers including: haematopoietic factors (IL-6,IL-8, IL-10, etc.), PD-L1 expression, T-cell subsets, T-cell immunoprecision typing and regulatory T-cell counts. The data from our study will provide the basis for further prospective clinical trials (Phase III).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Adebrelimab injection (1200mg) will be administered by intravenous infusion during the induction phase and maintenance phase on day 1 in a 3-week treatment cycle.
Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day.
Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
The First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, China
NOT_YET_RECRUITINGProgression-free survival (PFS)
To evaluate the efficacy of anti-tumor by Resist1.1 (In months)
Time frame: baseline up to approximately 6 month
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor by Resist1.1 (In percent)
Time frame: baseline up to approximately 6 month
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor by Resist1.1(In percent)
Time frame: baseline up to approximately 6 month
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Time frame: baseline up to approximately 12 months
Overall survival (OS)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Time frame: baseline up to approximately 12 month
Second progression-free survival (PFS2)
To evaluate the efficacy of anti-tumor by Resist1.1(In months)
Time frame: baseline up to approximately 12 months
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To identify the incidence of AE and SAE in clinical trial
Time frame: From the initiation of the first dose to 28 days after the last dose
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Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle.