Colorectal Cancer
Conditions
Interventions
Control Group:TAS102+Irinotecan ± Bevacizumab
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: All patients must meet the following criteria: 1. Sign the informed consent form, good compliance. 2. Age >=18 years (calculated on the date of signing the informed consent) . 3. Advanced or metastatic colorectal cancer diagnosed pathologically or radiographically has previously received first-line systemic therapy. Four. At least one measurable lesion according to RECUST 1.1 criteria. ECOG PS score 0-1. 6. Expected survival >=3 months.7. The function of the vital organs should meet the following requirements as far as possible (if the laboratory values do not meet the following criteria, after comprehensive assessment by the researchers, they can also be included in the register) : (1) routine blood test (without blood transfusion within 14 days, without the use of hematopoietic stimulator drugs to correct the state) : hemoglobin (HB)>=90 g/l; Absolute neutrophil count (ANC)>=1.5 x 109 l, platelet count (PLT)>=90 x 109 L, biochemical examination: Alanine transaminase (Alt) and aspartate transaminase (AST) 60 ml/min; Coagulation function: activated partial thromboplastin time (APTT) , international standard ratio (INR) , prothrombin time (PT)=50% . 8. Women of childbearing age need to take suitable contraception measures 3 months after screening and stopping study treatment, and they must be non-lactating subjects. Before starting administration, a pregnancy test was negative, or no pregnancy risk was demonstrated by meeting one of the following criteria: postmenopausal defined as age greater than 50 years and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; Women younger than 50 years of age who had amenorrhea for 12 months or more after discontinuation of all exogenous hormone therapy and whose Lutropin Alfa (LH) and follicle-stimulating hormone (FSH) levels were within the reference range of laboratory postmenopausal values, can also be considered postmenopausal; has undergone irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, with the exception of bilateral tubal ligation. 9. For men, consent is required to use appropriate methods of contraception or to have been surgically sterilized during the trial and 8 weeks after the last administration of the trial drug.
Exclusion criteria
Exclusion criteria: Any of the following should be excluded: 1. Any other malignant tumor within 5 years; 2. Pregnant or lactating women; 3. Allergy to chemotherapy drugs or their excipients; 4, known or suspected autoimmune diseases (including but not limited to: Uveitis, enteritis, hepatitis, pituitary, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring Bronchodilator treatment) . Patients with hypothyroidism who need only hormone replacement therapy and skin diseases that do not require systemic treatment, such as vitiligo, psoriasis or hair loss, may be enrolled; Major bleeding or ischemic events occurred within 6 months; major surgery was performed within 6 or 4 weeks; 7. Patients who had previously been treated with TAS-102; 8, myocardial infarction, severe unstable angina, NYHA Class 2 or higher heart failure, poorly controlled arrhythmias (including QTcF interval of 450ms in men and 470ms in women, calculated by Fridericia formula) , symptomatic heart failure, and cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism) ; 10. HIV positive; 11. History of substance abuse, alcohol abuse or drug abuse; 12. Severe liver and kidney dysfunction as judged by the researchers; Other factors that the researchers judged might affect patient safety or compliance. Such as serious illness (including mental illness) requiring combined treatment, serious laboratory abnormalities, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of TAS-102 combined with irinotecan combined with bevacizumab/cetuximab was observed; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress Free Survival;Objective response rate;Overall Survival;Disease control rate(DCR); | — |
Countries
China
Contacts
Public ContactChengxu Cui/Shuping Shi
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed