colorectal cancer
Conditions
Interventions
Experimental group:Microwave ablation combined with tirelizumab and fuquintinib
Sponsors
Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years (including the cut-off value); 2. Stage IV primary colorectal cancer confirmed by histopathology or cytology; 3. Metastases to one or more organs (oligometastases), and metastases evaluated by researchers as suitable for microwave ablation radiotherapy; 4. Failure to receive at least 2 lines of standard therapy (based on FU, oxaliplatin, irinotecan, bevacizumab, and cetuximab); Note: Adjuvant/neoadjuvant therapy is allowed. If relapse occurs during or within 6 months of completion of adjuvant/neoadjuvant therapy, adjuvant/neoadjuvant therapy is considered first-line therapy for advanced disease; 5. Have at least one extracranial measurable lesion that meets RECIST1.1 criteria; 6. If patients underwent surgery, they must recover sufficiently from the toxicity and complications of the surgical intervention prior to initiation of treatment before being considered for enrollment; 7. ECOG score: 0 ~ 1; 8. Expected survival >=12 weeks; 9. The functions of vital organs meet the following requirements (no blood components and cell growth factors have been used within 2 weeks prior to enrollment) : (1) Bone marrow function: neutrophil count >=1.5x10^9/L, white blood cell count >=4.0x10^9/L, platelet >=100x10^9/L, hemoglobin >=90g/L; (2) Liver: serum total bilirubin TBIL 1.5 times the normal upper limit, direct bilirubin level must = 50mL/min); (4) Heart: normal cardiac function, left ventricular ejection fraction (LVEF) >=50%; (5) Coagulation: INR<=1.5xULN, APTT<=1.5xULN; 10. Fertile male or female patients volunteered to use effective contraceptive methods, such as double screen contraceptives, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization (such as hysterectomy, bilateral adnexectomy or irradiation of radioactive ovaries). Otherwise, the serum of female patients showed no pregnancy (within 7 days prior to study enrollment), and must be non-lactating patients; 11. The patients voluntarily joined the study, signed the informed consent, and had good compliance.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-PD-1 /PD-L1 immune drugs or other experimental immune drugs; 2. Patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc.; 3. Symptomatic interstitial lung disease or active infection/non-infectious pneumonia; 4. The patient has risk factors for bowel perforation: active diverticulitis, intraperitoneal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for bowel perforation; 5. History of other malignant tumors; However, cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder carcinoma, prostate carcinoma in situ, cervical carcinoma in situ, and breast carcinoma in situ, could be included in the group; 6. Patients who are preparing for or have previously received an organ or allogeneic bone marrow transplant; 7. Moderate or severe ascites with clinical symptoms require therapeutic puncture or drainage or Child-Pugh score >2 (except those with only a small amount of ascites but no clinical symptoms shown on imaging); Uncontrolled or medium or above pleural effusion and pericardial effusion; 8. A history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 6 months prior to the start of treatment, such as: Patients with bleeding risk or severe esophageal and gastric varices, locally active digestive tract ulcer lesions, and persistent positive fecal occult blood could not be included in the group (if fecal occult blood was positive at baseline, it could be re-examined; if it was still positive after re-examination, gastroduodenal examination (EGD) was required; if EGD suggested bleeding risk, esophageal and gastric varices could not be included in the group); 9. Abdominal fistula, gastrointestinal perforation, or abdominal abscess developed within 6 months prior to the start of study treatment; 10. Known hereditary or acquired bleeding (e.g., cocoagulation disorders) or thrombotic tendencies, e.g., hemophiliacs; Currently using or recently (within 10 days prior to the start of study therapy) a full dose of oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (prophylactic low-dose aspirin, low molecular weight heparin allowed); 11. Currently receiving or recently receiving (within 10 days prior to the start of study treatment) aspirin (> 325 mg/ day (maximum antiplatelet dose) or dipyridamole, ticlopidine, clopidogrel (>=75mg) and ciloprazole; 12. The patient has an active infection; 13. Physical examination or clinical trial findings that the investigator believes may interfere with the results or put the patient at increased risk of treatment complications, or other uncontrollable diseases; 14. Congenital or acquired immunodeficiency diseases, including human immunodeficiency virus (HIV), or a history of organ transplantation or allogeneic stem cell transplantation; 15. Patients with mental illness, substance abuse or social problems that affect compliance were not included in the group after doctor's review; 16. Known active infection, active tuberculosis infection is not included in the group; However, patients infected with hepatitis B virus (HBV) and hepatitis C virus (HCV) can be enrolled if their condition is stable after antiviral
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective remission rate;disease control rate;overall survival; | — |
Countries
China
Contacts
Public ContactFang Cantu, Zhang Huatang, Meng Jincheng
Zhongshan Traditional Chinese Medicine Hospital Affiliated to Guangzhou University of Chinese Medicine
Outcome results
None listed