About this trial
To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Life expectancy of at least 3 months
Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
Disqualifiers
the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
the known presence of brain or pial metastases,
systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
Trial design
Single group
Treatments tested in this trial
Tas-102(Suyuan) combined with bevacizumab
DrugTas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks.
Treatment groups
Trial outcomes
Primary outcomes
Progression Free Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Secondary outcomes
Overall Survival
Time from randomization to death from any cause
Objective Response Rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)
Quality of life score
Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: