Colorectal adenocarcinoma
Conditions
Interventions
Experimental group 1:Regorafenib
Experimental group 2:TAS-102
Experimental group 3:single-center stereotactic radiotherapy (SBRT)
Sponsors
The Second Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-75 (including 18 and 75); 2. Understand the research steps and content, and voluntarily sign a written informed consent; 3. Multiple liver and/or lung metastases from unresectable or intolerant advanced colorectal adenocarcinoma confirmed by histopathology and/or cytology; lung metastases 700 cc. Liver metastases are >1.5cm away from the stomach and kidneys; 4. There is at least one measurable lesion, according to RECIST 1.1 criteria; 5. Patients with advanced colorectal adenocarcinoma who have previously received oxaliplatin, irinotecan and fluorouracil regimens; 6. Patients with recurrence or progression within 6 months after the end of second-line treatment and no toxicity of grade 2 or above; 7. Physical condition score (ECOG PS score): 0-2 points; 8. Expected survival period >= 3 months; 9. The main organs function well, that is, the relevant inspection indicators within 14 days before randomization meet the following requirements: Hemoglobin >= 90 g/L (no blood transfusion within 14 days); neutrophil count > 1.5x10^9/L; platelet count >= 100x10^9/L; total bilirubin = 60 ml/min (Cockcroft-Gault formula ); cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= 50%; thyroid function indicators: thyroid-stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range; normal coagulation function, liver function Child-Pugh class A or B; 10. Weight over 40 kg (including 40 kg), or BMI > 18.5; 11. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to randomization and must agree to be tested during the study and for at least 120 days after the last drug or placebo dose and at least after the last chemotherapy dose Use effective contraception for 180 days; 12. Non-sterilized females must agree to use highly effective contraception during the study period and for at least 120 days after the last dose and for at least 180 days after the last chemotherapy dose.
Exclusion criteria
Exclusion criteria: 1. Suffered from other malignant tumors in the past or at the same time. However, cured early tumors, including skin basal cell carcinoma, cervical carcinoma in situ, and stage I lung cancer can be included in the group; 2. Patients whose primary tumor is not resected; 3. Participated in other drug clinical trials within four weeks; 4.There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 5. There is a history of bleeding, and any bleeding event with a severity level of CTCAE5.0 of 3 or above in the 4 weeks before screening; 6. Patients with known central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to exclude central nervous system metastases; 7. Patients with hypertension who cannot be well controlled by a single antihypertensive drug treatment (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg); patients with a history of unstable angina; Patients newly diagnosed with angina within 3 months before screening or myocardial infarction occurred within 6 months before screening ;arrhythmia (including QTcF: male >=450 ms, female >=470 ms) requires long-term use of antiarrhythmic drugs and New York Heart Association grade >= Grade II cardiac insufficiency; 8. Long-term unhealed wounds or fractures with incomplete healing; 9. Imaging shows that the tumor has invaded important blood vessels or the researcher has judged that the patient's tumor is highly likely to invade important blood vessels and cause fatal bleeding during treatment; 10. Abnormal blood coagulation function, with bleeding tendency(any first 14 days must be satisfied: INR is within the normal range without anticoagulant, or abnormality with no clinical significance); patients who are treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; under the premise of prothrombin time international normalized ratio (INR) =++ and the 24-hour urine protein quantity is confirmed to be >1.0 g; 13. Those who have a history of psychotropic drug abuse and cannot be quit or have mental disorders; 14. Pleural effusion or peritoneal effusion with clinical symptoms that require clinical intervention; 15. Patients who do not follow the doctor's advice, do not use drugs according to the regulations, or have incomplete information, which may affect the efficacy or safety judgment; 16. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose, MTD;Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Objective response rate, ORR;Disease Control Rate, DCR;Duration of Response, DOR; | — |
Countries
China
Contacts
Public ContactWang Jirong
The Second Affiliated Hospital of Nanjing Medical University
Outcome results
None listed