advanced colorectal adenocarcinoma
Conditions
Interventions
Test group:Regorafenib combined with sintilimab
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years and =3.5×10?/L, neutrophil count >=1.5×10?/L, platelet count >=80×10?/L, hemoglobin >=90g/L (male) or >=100g/L (female); 7. Serum total bilirubin (TBIL) =50 mg/dl; prothrombin time international normalized ratio (INR) <=1.5×ULN, activated partial thromboplastin time (APTT) <=1.5×ULN; 8. Female participants of childbearing potential must agree to use effective contraceptive measures during the trial period; lactating women must stop breastfeeding during the trial period; 9. Patients voluntarily participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who have undergone gastrectomy and those with various conditions affecting oral drug absorption (such as dysphagia, gastrointestinal obstruction, chronic diarrhea, etc.); 2. Patients allergic to regorafenib, sintilimab, or any component of the drugs; 3. Patients who have received Chinese herbal medicines or proprietary Chinese medicines with anti-tumor indications within 1 week before enrollment; 4. Patients who refuse to sign the informed consent form or cannot understand the study content and thus cannot cooperate; 5. Patients with active tuberculosis (TB); 6. Patients who have had or currently have other malignant tumors within 5 years, except for cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors; 7. Patients with signs and symptoms of central nervous system metastasis and unstable condition; 8. Patients who have experienced any severe bleeding event of grade 3 or higher according to CTCAE 4.0 (Common Terminology Criteria for Adverse Events) within 4 weeks before screening; or patients with symptoms of gastrointestinal perforation or intestinal obstruction; 9. Patients with hereditary bleeding tendency or coagulation dysfunction, or those who have had arterial/venous thromboembolic events (such as cerebrovascular accident, myocardial infarction, deep vein thrombosis, and pulmonary embolism) within 6 months; 10. Patients with unhealed wound ulcers or fractures, or those who have undergone major surgery within 2 months before enrollment or are expected to undergo major surgery during the study period or within 2 months after the end of the study; 11. Patients with concurrent severe or uncontrolled medical diseases and infections; A. Active or uncontrolled severe infection (>= CTC AE grade 2 infection); B. Liver cirrhosis, decompensated liver disease, unexplained elevated transaminases, active hepatitis, or chronic hepatitis requiring antiviral treatment; C. History of immunodeficiency, including HIV positivity or other acquired congenital immunodeficiency diseases; D. Diabetic patients with poorly controlled blood glucose (fasting blood glucose (FBG) > 10 mmol/L); E. Poorly controlled hypertension (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg); F. Patients with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; according to NYHA (New York Heart Association) criteria, class III - IV heart failure, or left ventricular ejection fraction (LVEF) 100 beats/min, blood pressure < 90/60 mmHg, oxygen saturation < 90%), or severe anemia; 13. Patients with substance abuse or medical, psychological, or social conditions that may interfere with their participation in the study or the evaluation of study results; 14. Severe or uncontrolled mental illness or neurological diseases, including patients with epileptic seizures requiring treatment (e.g., steroid or antiepileptic therapy); 15. Patients receiving anti-cancer drug treatment in other clinical trials; 16. Female patients who are pregnant, breastfeeding, or expecting to be pregnant during the study period; 17. Patients deemed unsuitable for entry into this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;disease control rate;Quality of life; | — |
Countries
China
Contacts
Public ContactHuang Lumi
Chongqing University Cancer Hospital
Outcome results
None listed