Advanced malignant solid tumor
Conditions
Interventions
Gold Standard:Response Evaluation Criteria for Solid Tumors(RECIST V1.1)
Index test:Response Evaluation Criteria for Solid Tumors based on tumor markers (RecistTM v1.2)
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Advanced malignant solid tumors (small cell lung cancer, stage IV gastric colorectal cancer, stage IV breast cancer, stage IV cervical cancer, stage III-IV primary liver cancer); 2. The number of treatment lines and treatment plans is not limited, and tumor-related systemic therapy is planned, including immunotherapy, chemotherapy, and targeted therapy. For first-line treatment patients, tumor-related systemic therapy is required before enrollment, and for second-line treatment patients or above, it is required to clearly indicate imaging progression before enrollment and need to change treatment plans. 3. Any of the patient's main tumor markers (except CA72-4 and ferritin) is more than three times above normal within 15 days prior to enrollment, and the main tumor markers include but are not limited to: CEA>15ng/ml, CA-199>105U/ml, CA-153>105 U/ml, NSE>60 ng/ml, SCCAg>7.5 ng/ml, CYFRA21-1>10 ng/ml, ProGRP >195pg/m, AFP>60ng/ml, PIVKA-II>120mAU/ml,CA-125>105 U/ml,CA-242>105U/ml 4. Imaging test results and measurable lesions within 15 days before enrollment, measurable lesions that have not undergone radiotherapy; 5. PS score 0-2 points; 6. Age>=18 years old; 7. Major organ function is generally normal and relevant treatment criteria must be met: Routine blood tests must meet at least the following criteria before enrollment: (1) Hb>=70g/L; (2) ANC>=1.5×10^9/L; (3) PLT>=60×10^9/L; Biochemical examination must meet the following criteria: (1) ALT and AST45ml/min (Cockcroft-Gault formula). 8. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with an anticipated survival of less than 3 months. 2.Patients with two or more concurrent primary malignant solid tumors. 3.Patients with a history of psychoactive substance abuse that is not amenable to cessation or those with mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival based on tumor markers(tmPFS);Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Efficacy; | — |
Countries
China
Contacts
Public ContactXueqin Yang
Army Medical Center of PLA
Outcome results
None listed