The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received platinum-based chemotherapy and chest radiotherapy. 2-year survival rate of these patients is only about 10%. Therefore, this study aims to explore a comprehensive treatments with low toxicity to further improve the efficacy for these paitents with PD-1 inhibitor.
The study is a prospective pilot trial. The purpose of this study is to evaluate the safety and efficacy of PD-1 inhibitor consolidation in extensive-stage small cell lung cancer paitents who received standard first-line chemotherapy and chest radiotherapy ± SABR for metastasis disease. The primary endpoint is the safety and objective response rate of treatment. The secondary objectives are progression free survival(PFS), overall survial. The exploratory end point includes the correlation of PD-1 expression on the tumor tissue, and the TMB, Immune Repertoire sequencing derived from the tumor tissue and the blood sample with the efficacy of treatent. The plan for collection of tumor tissue and blood at baseline at different stages during or after treatment was defined in the protocol. The PICCARE-trial has been designed by National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, and the hypothesis is PD-1 inhibitor consolidation was safe and effective in the treatment of extensive-stage SCLC after sandard first-line chemotherapy and radiotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The extensive-stage SCLC patients will receive PD-1 inhibitor treatment after standard first-line chemotherapy, chest radiotherapy ± SABR for metastasis disease, and propylactic cranial irradiation untill disease progression or death.
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Adverse events
The incidence and severity of adverse events related to treatments
Time frame: At least 1 year following the conclusion of immunotherapy
Objective remission rate
Objective remission rate (ORR): refers to the proportion of subjects in the analyzed population who achieved complete remission (CR) or partial remission (PR); according to the tumor immunotherapy efficacy evaluation (irRC) and RECIST criteria (v1.1) by the evaluation of investigator.
Time frame: 24 weeks following the conclusion of immunotherapy
Pharmacodynamic indicators
Pharmacodynamic indicators,such as the detection of PD-1 receptor occupancy in the blood
Time frame: During and 6 weeks after the treatment of immunotherapy
Continuous remission time (DOR)
DOR was defined as time since onset of CR or PR to relapse or death due to underlying cancer, whichever is earlier
Time frame: At least 1 year following the conclusion of immunotherapy
Disease Control Rate (DCR)
The percentage of patients who have achieved complete response, partial response and stable disease to the therapeutic intervention
Time frame: At least 1 year following the conclusion of immunotherapy
Time to response (TTR)
The time from the start of treatment to the first objective tumor response
Time frame: 24 weeks following the conclusion of immunotherapy
Progression-free survival (PFS)
The length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse
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Time frame: At least 1 year following the conclusion of immunotherapy
Overall survival (OS)
The time from treatment to death from any cause
Time frame: At least 1 year following the conclusion of immunotherapy