Colorectal cancer
Conditions
Interventions
Experimental group:TAS-102:35 mg/m2 (maximum single dose of 80 mg), once in the morning and once in the morning, 2 days rest after 5 consecutive days, another 5 days rest for 2 days, and then 14 days
Sponsors
Hebei General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Sign a written ICF voluntarily. 2) Age =18 years old, =75 years old at the time of enrollment. 3) The Eastern Cancer Collaboration (ECOG) Physical fitness score was 0 or 1. 4) Expected survival = 3 months. 5) Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma. 6) The subjects were colorectal cancer patients who were not suitable for radical surgical resection or local treatment and had previously received 2-line systemic antitumor therapy; 7) At least one measurable lesion according to RECIST v1.1. Note: Brain metastases cannot be used as target lesions. The lesion should not be used as a target lesion after radiotherapy unless the progression is clearly demonstrated on imaging. 8) Determine good organ function by: a) Hematology (no blood components and growth factor branches were used within 7 days prior to the start of the study treatment Hold treatment) : i. Absolute value of neutrophil ANC = 1.5 ×109/L (1,500/mm3); ii. Platelet count = 100 × 109/L (100,000/mm3); iii. Hemoglobin = 90 g/L. b) Kidney: i. Creatinine clearance * (CrCl) calculated value = 50 mL/min, or Serum creatinine (Cr) = 1.5×ULN * CrCl will be calculated using Cockcroft-Gault formula (Cockcroft-Gault formula) CrCl (mL/min) = {(140 - age) * F} weight (kg)/(SCr (mg/dL) x 72) F=1 for males; For women, F = 0.85; SCr = serum creatinine. ii. Urinary protein < 2+ or 24-hour (h) urinary protein quantity < 1.0 g. c) Liver: i. Serum total bilirubin (TBil) = 1.5 × ULN; For liver metastases or with evidence confirmed/suspected Subjects with Gilbert disease had TBil = 3 × ULN ii. AST and ALT = 2.5 x ULN; For subjects with liver metastasis, AST and ALT = 5× ULN iii. Serum albumin (ALB) =28 g/L d) Coagulation function: i. The internationally standardized ratio and activated partial thromboplastin time = 1.5 × ULN (unless the subject is receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at the time of screening). e) Heart function: i. Left ventricular ejection fraction (LVEF) =50%. 9) Fertile female subjects must undergo a urine or serum pregnancy test within 3 days prior to the first dose (If the urine pregnancy test results are not confirmed as negative, a serum pregnancy test is required to determine the serum pregnancy If) and the result was negative. Such as a fertile female subject with an unsterilized male partner To have sex, the subject must start using an acceptable contraceptive method since screening, and must consent to having sex Study continued use of contraceptive methods for 120 days after the last dose of the drug; About after this point in time is Whether to stop contraception should be discussed with the researcher. 10) If an unsterilized male subject has sex with a fertile female partner, the subject must use an effective contraceptive method from the beginning of screening until the 120th day after the last dose; Whether to stop contraception after this time point should be discussed with the investigator. 11) The subject is willing and able to comply with scheduled visits, treatment protocols, laboratory tests, and other requirements of the study.
Exclusion criteria
Exclusion criteria: 1) Prior (within 3 years) or concurrent with other malignant tumors, except local tumors that have been cured (such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, etc.). 2) Have participated in the treatment of the investigational drug or used the investigational device within 4 weeks prior to the initial study administration. 3) Palliative local treatment was performed for non-target lesions within 2 weeks before the first administration; Received non-specific immunomodulatory therapy (e.g., interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks prior to initial administration; Received Chinese herbal medicine or proprietary Chinese medicine with anti-tumor indications within 1 week prior to the first administration. (Can it be deleted?) 4) Patients with active autoimmune disease that has required systemic treatment within the past two years (e.g., treatment with disease-modifying drugs, corticosteroids, immunosuppressants) and replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered a systemic treatment. (don't understand) 5) Active or have a clear history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea). 6) History of immune deficiency; HIV antibody test positive; Systemic corticosteroid hormones or other immunosuppressants are currently being used on a long-term basis. 7) Subjects with known active tuberculosis (TB) and suspected active TB need to be excluded by clinical examination; Known active syphilis infection. 8) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 9) Previous history of non-infectious pneumonitis/interstitial lung disease requiring systemic glucocorticoid therapy or current presence of non-infectious pneumonitis. 10) Serious infection, including but not limited to comorbidities, sepsis, or severe pneumonia requiring hospitalization within 4 weeks prior to the first dose; Active infection (excluding antiviral therapy for hepatitis B or C) that has received systemic anti-infective therapy within two weeks prior to the first dose. 11) Subjects with current active hepatitis B (HBsAg positive and HBV-DNA more than 1000 copies/ml (200 IU/ml) or above the lower limit of detection, whichever is higher). Note: For subjects with hepatitis B, anti-hepatitis B virus therapy is required during study treatment. 12) Subjects with active hepatitis C (HCV antibody positive and HCV-RNA levels above the lower limit of detection). 13) Those who have had major surgical operations or serious traumatic injuries within 30 days prior to the first dose, or who have planned major surgical procedures within 30 days after the first dose (at the discretion of the investigator); Minor local surgery (excluding peripheral venous catheterization and intravenous port implantation) within 3 days prior to the first dose. 14) Presence of active central nervous system (CNS) metastases; Subjects with previously treated brain metastases who are clinically stable for at least two weeks after treatment (calculated from the first dose of study drug) and who discontinue corticosteroids 3 days prior to study drug administration are allowed to enroll; Subjects with untreated, asymptomatic brain metastases (i.e., no neurological symptoms, no c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of remission;Time to remission;Overall survival; | — |
Countries
China
Contacts
Public ContactJia Yitao
Hebei General Hospital
Outcome results
None listed