This study is a single-arm, prospective, open-label observational clinical study to evaluate the efficacy and safety of Bevacizumab combined with Oxaliplatin and TAS-102 in patients with advanced unresectable rectal cancer.
age: ≥18 years and ≤75 years;
ECOG score 0~1 points;
advanced colorectal cancer patients
According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose;
Patients who have received first-line standard therapy;
Previous antitumor therapy or radiation therapy for any malignant tumor;
concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
Has undergone major surgical procedures not related to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
Single group
Bevacizumab combined with Oxaliplatin and TAS-102
DrugBevacizumab (Anda, Qilu Pharmaceutical): 5 mg/kg, repeated every 2 weeks, administered by intravenous drip (ivgtt). Oxaliplatin: 85 mg/m2, repeated every 2 weeks, by intravenous infusion (ivgtt). TAS-102: 35 mg/m2 (maximum single dose 80 mg), orally, twice a day, on days 1 to 5, repeated every 2 weeks. Continuous administration until disease progression, death, toxicity intolerance, withdrawal of informed consent, or other reasons specified in the protocol; for patients who still benefit after comprehensive evaluation after initial disease progression, the investigator may decide whether to continue the treatment with the experimental drug .
Progression Free Survival (PFS)
Defined as the time from randomization to tumor progression in any aspect or death from any cause（Unit: month）. Assessed according to RECIST 1.1 criteria, analysis of this indicator included tumor evaluation results during study treatment and follow-up. If the patient has several indicators that can be determined as PD, the first indicator is used for PFS analysis; recurrence, new lesions or death are considered to have reached the study endpoint 1. The patient uses other systemic or targeted observation targets. Lesional anti-tumor therapy is also considered tumor progression.
Disease Control Rate (DCR)
Defined as the number of subjects whose tumors shrank or remained stable for a certain period of time, including complete remission (CR) and partial remission (PR), during the period from the time the subject received the treatment regimen of this study to the progression of the subject's disease in the analysis data set The percentage of the total population (unit: %). Evaluation method: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). Subjects must have measurable tumor lesions at baseline. The efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Subjects assessed as CR, PR, and SD were confirmed after 3 weeks (at the next protocol-specified efficacy assessment).
Objective response rate (ORR)
It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population（%）.
Overall survival (OS)
Defined as the time from randomization to death from any cause（Unit: month）.
Drug-Related Safety Indicators
Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events（n，%）。
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