Evaluate the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD(Stable Disease) status in the real world.
This is a prospective interventional clinical trial investigating the efficacy and safety of Nocardia rubra cell wall skeleton in combination with prior second- or third-line regimens for the treatment of potentially hazardous colorectal cancer SD (Stable Disease) status in the real world. Enrollment requirements were patients who had received prior second- or third-line therapy for advanced or metastatic colorectal cancer and presented with a potentially harmful SD status. The potentially hazardous SD (Stable Disease) state is defined as an increase in SLD (Sum of Longest Diameters) by less than 20% according to RECIST 1.1 criteria, with an absolute increase of SLD ≤ 5mm from the nadir; a serum CEA (Carcinoembryonic Antigen) level below 10.0 ng/ml during stable disease, with two consecutive measurements of 10 ng/ml or more (with a testing interval of at least one month); or a serum CEA level of 10 ng/ml or more during stable disease, with a gradual increase in CEA after two consecutive measurements (with a testing interval of at least one month); a serum CA19-9 level below 60.0 ng/ml during stable disease, with two consecutive measurements of 60 ng/ml or more (with a testing interval of at least one month); or a serum CEA level of 60 ng/ml or more during stable disease, with a gradual increase in CEA after two consecutive measurements (with a testing interval of at least one month). Meeting any one of the above criteria can be considered as the presence of a potentially hazardous SD state.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Nocardia Rubra Cell Wall Skeleton 200 mcg-400 mcg, 0.3 ml diluted in water for injection or lidocaine, was injected subcutaneously every 2 or 3 weeks. Efficacy was evaluated every 2 cycles according to RECIST 1.1 criteria. Patients are enrolled and given this study regimen of drugs on top of their prior second- or third-line regimen until disease progression or intolerable toxicities occur; or the patient requests to be discharged.
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGProgression-free survival(PFS)
Time between the start of a treatment regimen and tumor progression or death
Time frame: 1 year
Overall survival (OS)
Time frame: 2 year
Objective remission rate (ORR)
Time frame: 1 year
Disease Control Rate (DCR)
Time frame: 1 year
Incidence and extent of major security incidents
Time frame: 1 year
Quality of Life Score (QoL) for tumor patients
Time frame: 1 year
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