colorectal cancer
Conditions
Interventions
Observation group:fruquintinib combined with standard chemotherapy
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Metastatic colorectal adenocarcinoma confirmed by histopathology or cytology; 3. The primary tumor has previously received chemotherapy based on fluorouracil (5-fluorouracil, capecitabine, and tegio), oxaliplatin, or irinotecan. This visit is intended to receive the treatment of furoquinotinib combined with standard chemotherapy; 4. The score of ECOG-PS is 0-1; 5. Able to swallow oral drugs; 6. At least 7 days from the end of the last systematic treatment, the patient is allowed to receive palliative radiotherapy for limited parts, which has been over 4 weeks; 7. According to the evaluation standard of curative effect of solid tumor (RECIST V1.1), at least one measurable focus; 8. The expected survival period is 3 months and can receive long-term follow-up; 9. Have sufficient organ and bone marrow functions; 10. The patient fully understood the study and voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or effectively resected cervical carcinoma in situ, breast cancer; 2. At the same time, they receive other experimental drugs or anti-tumor treatment approved or under research; 3. There are many factors affecting oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea and intestinal obstruction); 4. It has been proved that it is allergic to any component of the test drug and its excipients; 5. Other conditions that may cause severe gastrointestinal bleeding and perforation determined by patients or researchers with any physical signs or medical history of bleeding; 6. Patients whose adverse events (excluding hair loss) caused by previous treatment have not recovered to = CTC AE 1 degree; 7. Patients with any serious and/or uncontrolled disease; 8. Patients with massive pleural effusion or ascites that need drainage; 9. Patients who are pregnant or have a pregnancy plan; 10. Patients judged by the researcher as unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year PFS ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;mOS;mPFS;Safety; | — |
Countries
China
Contacts
Public ContactYongshun Chen
Renmin Hospital of Wuhan University
Outcome results
None listed