Colorectal cancer
Conditions
Interventions
Cohort 1:Fruquintnib combined with TAS-102 and SBRT
Cohort 2:Fruquintnib combined with TAS-102
Sponsors
Ningbo No.2 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Understand the research steps and content, and voluntarily sign a written informed consent; 2) Subjects aged 18-75 (including 18 and 75);ECOG PS: 0-1 points;Expected survival period >3 months; 3) Histologically confirmed adenocarcinoma of advanced colorectal cancer who had failed standard first - and second-line treatment; 4) Patients who can provide previously stored tumor tissue specimens or conduct biopsy to collect tumor lesion tissue for detection of k-ras, N-ras, BRAF, MSI/MMR expression; 5) At least one measurable lesion according to RECIST 1.1; 6) Good organ function (no blood transfusion, no hematopoietic stimulating factor, no infusion of albumin or blood products within 14 days prior to screening): a.Hemoglobin >=90g/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; b.ALT and AST = 50 mL/min e.Serum albumin >=30g/L; f.International normalized ratio (INR), activated partial thromboplastin time (APPT) =50%. 7)Female participants of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to receiving the first dose of study medication. If the urine test is positive or cannot beconfirmed as negative, a serum pregnancy test will be required. A female of childbearing potential is defined of one who is biologically capable of becoming pregnant. Reliable contraception should beused starting from trial screening and must be continued throughout the study)
Exclusion criteria
Exclusion criteria: 1) Combined disease and history a. Patients with malignant disease other than the treated tumor of the study within 3 years(exceptions include: cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basal membrane)]). b. Having multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); c. Gastrointestinal bleeding or perforation was occurred or tended to occur during the first 4 weeks of enrollment d. Patients with ulcerative colitis, Crohn's disease and active inflammatory bowel disease within the first 4 weeks of enrollment; e. Uncontrolled pleural effusion, ascites, and moderate or above pericardial effusion requiring repeated drainage; f. Unmitigated toxic reactions =grade 1 according to CTCAE due to any prior treatment, excluding alopecia; g. Received major surgical treatment, open biopsy, or significant traumatic injury (except gastroenteroscopic tissue biopsy) within 28 days prior to enrollment h. Patients who developed hematemesis, hematochezia, or any bleeding event =grade 3 according to CTCAE within 3 months prior to screening, or who had any signs of bleeding or had a history that the investigator determined was not suitable for enrollment, regardless of severity; i. The presence of open wounds, ulcers or fractures; j. Experienced arteriovenous thrombosis, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc., occurred within 6 months; k. A history of psychotropic substance abuse and inability to abstain; i. Subjects with any severe and/or uncontrolled medical condition; 2)Related to study therapy a. Live vaccine within 4 weeks before study medication b. Known allergy to study drugs or excipients, or allergy to similar drugs c. Systemic therapy had occurred within 2 years prior to enrollment d. Diagnosed with immunodeficiency or were receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy and continued use within 2 weeks of initial administration 3) Participated in clinical trials of other antitumor drugs before enrollment 4) The investigator judged other causes of unsuitability for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival assessed by the investigator; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DOR;Association between biomarkers (k-ras, N-ras, BRAF, MSI/MMR condition, etc.) and the effect of combination therapy; | — |
Countries
China
Contacts
Public ContactZhang Chen; Wang Yi
Ningbo No.2 Hospital
Outcome results
None listed