Recurrent or Metastatic Advanced Cancer
Conditions
Interventions
Experimental group:Glucose Metabolism Regulation Combined with Anti-Tumor Regimen
Sponsors
The First Hospital of Jiaxing
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years old, both male and female are eligible. 2. Histologically or cytologically confirmed recurrent or metastatic malignant tumors. 3. No previous systemic anti-tumor treatment for advanced or metastatic solid tumors, and planned to receive intravenous infusion of anti-tumor drugs (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, and chemotherapy combined with targeted therapy). The following situations are allowed to be included: subjects who have received adjuvant or neoadjuvant anti-tumor treatment (including chemotherapy, immunotherapy, and targeted therapy), with at least 6 months between the last dose of adjuvant or neoadjuvant anti-tumor treatment and disease recurrence. 4. According to RECIST v1.1, there must be at least one measurable lesion. Lesions that have received radiotherapy cannot be selected as target lesions, unless the radiotherapy lesion is the only measurable lesion and is clearly progressing based on imaging, it can be considered as a target lesion. The basic criteria for including target lesions are: the long diameter of the tumor lesion >= 10mm or the short diameter of the pathological lymph node >= 15mm. The sum of the long diameter of the tumor target lesion and the short diameter of the pathological lymph node target lesion is used as the basis for quantitative assessment. The selection criteria for non-target lesions are: the long diameter of the tumor lesion = 10mm and = 12 weeks. 7. The functions of important organs meet the following requirements: absolute neutrophil count (ANC) >= 1.5×10^9/L; platelets >= 100×10^9/L; total bilirubin 60 mL/min (calculated by Cockcroft-Gault formula); activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) <= 1.5 × ULN. 8. For female subjects of childbearing age, the blood pregnancy test must be negative within 7 days before the first administration of the study drug, and for male subjects whose partners are of childbearing age, at least one medically approved contraceptive measure (such as intrauterine device, contraceptive pills, or condoms) must be used during the study treatment period. 9. The expected intravenous infusion time of the anti-tumor drug does not exceed 1.5 hours. 10. The subject voluntarily participates in this study, fully understands the study, signs the informed consent form, has good compliance, and cooperates with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who progress after 4 treatment cycles (including hyperprogression); 2. Patients with gastrointestinal obstruction and unable to receive enteral nutrition through the mouth or nasogastric tube; 3. Patients with systemic infection or other severe infections (including but not limited to pulmonary infection, intestinal infection, sepsis, etc.) requiring intravenous or oral antibiotics for more than 7 days within 2 weeks before randomization, or with unexplained fever > 38.5 ? during the screening period or before enrollment (excluding fever caused by tumor as judged by the investigator); 4. Patients with brainstem, leptomeningeal, spinal cord metastases or compression or active bleeding; 5. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases who have been clinically stable for at least 2 weeks before the first dose, with no evidence of new or enlarged brain metastases, and have discontinued steroids for at least 3 days before the study drug administration can be included in the study. According to this definition, the stability of brain metastases should be determined before the first dose of the study drug. Patients with known untreated asymptomatic brain metastases (i.e., no neurological symptoms, no need for corticosteroid treatment, and no or only mild perifocal edema) can be included in the study, but regular brain imaging is required to assess the metastases; 6. Patients with active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); except for patients with vitiligo or childhood asthma/allergy that has been cured and does not require any intervention in adulthood; patients with autoimmune-mediated hypothyroidism treated with a stable dose of thyroid replacement hormones; patients with type 1 diabetes treated with a stable dose of insulin; 7. Patients with a history of immunodeficiency, including positive HIV antibody test, or with other acquired or congenital immunodeficiency diseases, or with a history of organ transplantation and allogeneic bone marrow transplantation; 8. Patients with uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) unstable angina; (3) myocardial infarction within 6 months; (4) clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain uncontrolled after clinical intervention; 9. Patients with known active or suspected autoimmune diseases. Patients in a stable state who do not require systemic immunosuppressive therapy are allowed to be included; 10. Patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), and HBV-DNA = 500 IU/mL or 2500 copies/mL at the time of enrollment. For those above this standard, they must first receive antiviral treatment and the HBV-DNA must be reduced to the normal range for at least 2 weeks before enrollment, and must continue antiviral treatment throughout the study. For patients who have previously required or are currently receiving antiviral treatment at the time of screening, even if the HBV-DNA meets the inclusion criteria, they must continue antiviral treatment throughout the study to be incl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactSong Binbin
The First Hospital of Jiaxing
Outcome results
None listed