Colorectal cancer
Conditions
Interventions
Experimental group:TAS102 in combination with furquintinib
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1) Age greater than 18 years old, gender is not limited; 2) Confirmed as metastatic colorectal cancer by histopathological examination; 3) Metastatic colorectal cancer that has previously failed second-line therapy: a) Treatment failure is defined as: intolerable toxicity or disease progression during treatment or tumor recurrence or metastasis after treatment ends; b) one or more chemotherapy drugs with a duration of each line of treatment = 1 cycle or more; Early adjuvant/neoadjuvant therapy is allowed, and if tumor recurrence and metastasis occur during or within =24 weeks of completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered systemic chemotherapy; c) allow early treatment to be targeted drugs, immunosuppressants or radiotherapy; d) Permitted upfront treatment is chemotherapy combined with targeted drugs. 4) at least one measurable lesion (RECISIT version 1.1 compliant); 5) expected survival time= 12 weeks; 6) ECOG physical condition 0-1 points; 7) The subject's main organs were functionally normal, and the blood routine, liver, kidney function and heart function were basically normal. Meet the following requirements: ? Routine blood routine (no transfusion within 14 days): HGB=80g/L; ANC=1.5×10^9/L; PLT=80×10^9/L. ? Blood biochemistry: TB (total bilirubin) = 1.5 times the upper limit of normal value (ULN); or =3 times ULN in the case of liver metastasis; ALT and AST = 2.5 times ULN, or 5 times ULN in the presence of liver metastases=; Serum CR= 1.5 times ULN; endogenous creatinine clearance = 50 ml/min (Cockcroft-Gault formula). 8) Patients or family members can understand the research plan and are willing to participate in the study, and sign a written informed consent form; 9) Patients have good compliance and voluntarily receive follow-up, treatment, laboratory tests and other research steps as planned.
Exclusion criteria
Exclusion criteria: 1) Patients with a history of other malignancies, including concurrent colorectal multiple primary tumors, but are allowed to include adequately treated non-melanoma skin cancer, effectively treated cervical carcinoma in situ, or patients with other solid tumors that have been effectively treated with surgery or surgery combined with radiotherapy and/or chemotherapy and have been cured for 5 years or more after the end of treatment. 2) Patients who have undergone major surgery within 4 weeks prior to randomization. 3) poorly controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure >100 mmHg), and subjects with a history of hypertensive crisis or hypertensive encephalopathy; 4) Have bleeding tendency, high bleeding risk or coagulation dysfunction; 5) Patients with known brain metastases or ponticulous metastases, whether treated or not, were not included in this trial. 6) Pregnant or lactating women. 7) Gastrointestinal disorders that significantly affect the absorption of oral drugs (such as intestinal obstruction, Crohn's disease, ulcerative colitis, extensive gastric and small bowel resection). 8) Severe liver and kidney function or cardiac insufficiency; 9) Known human immunodeficiency virus (HIV) infection. Known active infection with hepatitis B virus or hepatitis C virus. 10) Patients with uncontrollable ascites or pleural effusion, such as needing to drain fluid within 2 months before randomization, or need to discharge fluid repeatedly or in large quantities, or need to have an indwelling drainage catheter. 11) Patients with known microsatellite instability (MSI-H) or mismatch repair defects (dMMR). 12) Known allergy to fluoropyrimidines. 13) Any situation (e.g., spiritual, geographical, etc.) that cannot be followed by the plan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;OS;PFS;AE; | — |
Countries
China
Contacts
Public ContactYifu He
Anhui Provincial Cancer Hospital
Outcome results
None listed