This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens.
This study is a prospective, multicenter, open-label, umbrella phase II clinical trial. Based on different multigene expression profiling subtypes and potential molecular characteristics of various pathways, 8 treatment arms and 13 treatment groups are preliminarily designed. After successful screening, investigators will assign eligible subjects to a treatment group based on the patient's genetic test report (if available) and performance status. For subjects without a genetic test report, they will be allocated to Arm H to receive immunotherapy combined with chemotherapy or other regimens. The mutations involved include the following: A: FGFR, B: IDH1, C: KRAS, D: NTRK, E: BRAF V600E, F: BRCA1/2, G: HER2, and H: pan-negative. Additional corresponding targets may be added later based on clinical practice.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
FGFR Inhibitor
IDH1 mutation inhibitor
KRAS mutation inhibitor
NTRK mutation inhibitor
BRAF V600E mutation inhibitor
BRCA 1/2 mutation inhibitor
HER2 target therapy
Immune Checkpoint Inhibitors
Chemotherapy: GP/GEMOX
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of subjects in the analysis population who have a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1.
Time frame: From enrollment to upto 2 years
Progression-Free Survival (PFS)
Progression-Free Survival (PFS), defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: From enrollment to upto 2 years
Overall Survival (OS)
Overall Survival (OS), defined as the time from randomization to death from any cause.
Time frame: From enrollment to upto 3 years
Disease Control Rate (DCR)
Disease Control Rate (DCR), defined as the percentage of patients with confirmed complete response, partial response, or stable disease (≥ 8 weeks) among efficacy-evaluable patients.
Time frame: From enrollment to upto 2 years
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