Advanced colorectal cancer
Conditions
Interventions
test group:Fosapitam+mFOLFOX6/FOLFIRI/CAPEOX+bevacizumab
control group:mFOLFOX6/FOLFIRI/CAPEOX+bevacizumab
Sponsors
The 903rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Male or female, age = 18 years old, = 75 years old; (2) Metastatic colorectal adenocarcinoma confirmed by histology, with unresectable metastatic lesions; (3) MSS type, RAS/BRAF gene status unlimited; (4) ECOG physical fitness status is 0 to 1 point; (5) The expected lifespan is at least 12 weeks; (6) Hematological examination: Absolute neutrophil count (ANC)>1.5 × 109/L, hemoglobin>8g/dL, and platelets>100 × 109/L (based on normal values in clinical trial centers); (7) Prothrombin time (PT)<1.5 times the upper limit of normal value and normal thromboplastin time (APTT)<1.5 times the upper limit of normal value; (8) Serum creatinine is less than or equal to 1.5 times the upper limit of the normal reference range (if serum creatinine increases, 24-hour urine must be collected, except for those with a creatinine clearance rate greater than 50ml/min within 24 hours); (9) When there is no liver metastasis, ALT or AST is less than or equal to 2.5 times the upper limit of the normal reference range, and serum total bilirubin is less than or equal to 1.5 times the upper limit of the normal reference range; For patients with liver metastasis, ALT or AST is less than or equal to 5 times the upper limit of the normal reference range, and serum total bilirubin is less than or equal to 3 times the upper limit of the normal reference range; (10) Women of childbearing age must be willing to use adequate contraceptive measures during the study drug treatment period; (11) Signed informed consent form; (12) According to the definition of RECIST 1.1, researchers have determined that patients have measurable diseases. If the tumor lesion located within the previous radiotherapy area is confirmed to have progressed, it is considered measurable.
Exclusion criteria
Exclusion criteria: (1) Active autoimmune diseases that require systemic treatment (i.e. the use of disease relieving drugs, corticosteroids, or immunosuppressants) have occurred within the past 2 years. Alternative therapies (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments. (2) Diagnosed as immunodeficiency or undergoing systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first administration of the trial treatment. After consulting with the sponsor, the use of physiological doses of corticosteroids may be approved. (3) Adverse events caused by receiving anti-tumor monoclonal antibodies (mAb) within 4 weeks prior to the first day of the study, or receiving medication before 4 weeks without recovery (i.e. = level 1 or reaching baseline level). (4) Adverse events caused by chemotherapy, targeted small molecule therapy, or radiation therapy received within 2 weeks prior to the first day of the study, or previously received drugs that have not yet recovered (i.e. = level 1 or reaching baseline level). Note: Subjects with = grade 2 neuropathy or = grade 2 hair loss are considered exceptions to this standard and may be eligible to participate in the study. If the subjects have undergone major surgery, they must fully recover from the toxicity and/or complications caused by the intervention measures before starting treatment. (5) It is known that there are other malignant tumors that are progressing or require active treatment. Excluding skin basal cell carcinoma, skin squamous cell carcinoma, or cervical carcinoma in situ that have already undergone curative treatment. (6) It is known that there is active central nervous system (CNS) metastasis and/or cancerous meningitis. Subjects who have received brain metastasis treatment before can also participate in this study, provided that their condition is stable (there is no disease progression confirmed by imaging examination at least 4 weeks before the first administration of the trial treatment, and all neurological symptoms have returned to baseline levels), there is no evidence of new or expanded brain metastasis, and steroid treatment is discontinued at least 7 days before the first administration of the trial treatment. This exception does not include cancerous meningitis, which should be excluded regardless of its stable clinical condition. Has a history of pneumonia (non infectious) requiring steroid treatment or is currently suffering from pneumonia (non infectious). (7) Active infections that require systemic treatment. (8) There is a possibility of confusing the trial results, obstructing the participant's full participation in the study due to medical history or evidence of illness, abnormal treatment or laboratory values, or the researcher believing that participating in the study is not in the best interest of the participant. (9) It is known that there are mental or substance abuse disorders that may affect compliance with the trial requirements. (10) Female participants who are pregnant or breastfeeding, or expected to conceive during the planned trial period or 180 days after the last dose of study treatment, or male participants who have caused their spouses to become pregnant. (11) Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive). (12) Known to have active hepatitis B or C. Active hepatitis B is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progressive Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);Overall Survival (OS);Disease Control Rate; | — |
Countries
China
Contacts
Public ContactXi Wang; Caiyun Fu
The 903rd Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Outcome results
None listed