A Phase II, open label, non-randomized, multiple-arm, single-center clinical trial in patients with advanced rare solid tumors who failed to standard treatment.
Name: Almonertinib 110 MG
Name: Dacomitinib 45 MG
Name: Alectinib 150 MG
Name: Crizotinib 250 MG
Name: Pyrotinib 160/80 MG
Name: Imatinib 400 MG
Name: Niraparib 200/300 MG
Name: Palbociclib 125mg
Name: Vemurafenib 240 MG
Name: Sintilimab 100MG
Name: Atezolizumab 1680 MG
Description: The percentage of patients with a confirmed Blinded Independent Central Review (BICR) and investigator-assessed complete or partial response according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1.
Measure: Objective Response Rate (ORR) Time: Measured from first dose until confirmed response or progression, assessed up to 2 years.Description: The time from first dose until the date of objective disease progression or death (by any cause in the absence of progression).
Measure: Progression-Free Survival (PFS) Time: Measured from first dose until progression, assessed up to 2 years.Description: The interval between the initiation of study treatment and the first documentation of CUPD (second confirmation of Disease Progression) or death due to any cause as defined by the iRECIST standard in the single drug immunotherapy group
Measure: iRECIST Evaluated Progression Free Survival (iPFS) Time: Measured from response until progression, assessed up to 2 years.Description: The time from the date of first response until date of disease progression or death in the absence of disease progression.
Measure: Duration of Response (DoR) Time: Measured from response until progression, assessed up to 2 years.Description: The percentage of patients treated with targeted and single immunotherapy assessed by the investigator,
Measure: Disease Control Rate (DCR) Time: Measured from first dose until confirmed response or progression, whichever came first, assessed up to 2 years.Description: Partial Response (PR) or Complete Response (CR) or Stable Disease (SD) in the single drug immunotherapy group and without Disease Progression at more than six months.
Measure: Durable Clinical Benefit (DCB) Time: Measured from first dose until confirmed response or progression, whichever came first, assessed up to 2 years.Description: The median survival time of patients
Measure: Overall survival (OS) Time: Measured from first dose until death or final cohort data cut-off, whichever came first, assessed up to 2 years.Description: Percentage of patients who is alive at 1-year from first dose of treatment.
Measure: One year of Overall Survival rate (1-year OS rate) Time: Measured from first dose until death, assessed up to 2 years.Description: To evaluate safety and tolerability of each study treatment.
Measure: Incidence of Adverse Events (AE) in subjects Time: Continuously from first dose to end of safety follow up after study treatment discontinuation, assessed up to 2 years.Description: The proportion of patients who are alive and progression-free more than 6 months after the first dose of study therapy Progression-free Survival (PFS) the proportion of patients with PFS ≥ 6 months in the total enrollment since the start of the study.
Measure: The 6-month PFS rate Time: Measured from response until progression, assessed up to 2 years.Allocation: Non-Randomized
Parallel Assignment
There is one SNP
Patients with advanced rare tumors who failed to standardized treatment carrying actionable alterations as "EGFR mutation (exon 19 deletion mutation, L858R replacement mutation), ALK gene fusion, ROS-1 gene fusion, C-MET gene amplification or mutation (D1010 mutation, 14 exon mutation, y1003 mutation), BRAF mutation, CDKN2A mutation, BRCA1/2 mutation, HER-2 mutation, HER-2 over expression/amplification, C-KIT mutation", will enroll targeted therapy arms and be given corresponding targeted drugs (Dacomitinib, Crizotinib). --- L858R ---