Gastrointestinal Tumors with Unresectable Liver Metastasis
Conditions
Interventions
Colorectal cancer with liver metastasis group:Anlotinib and CAPEOX(oxaliplatin and capecitabine)
Esophageal squamous cell carcinoma with liver metastasis group:Anlotinib and TP/DP(combination chemotherapy with paclitaxel and cisplatin)
Other gastrointestinal tumors with unresectable liver metastasis group:Anlotinib and standard first-line chemotherapy
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up; 2. Aged 18 to 75 years; 3. Histologically or cytologically confirmed IV phase of colorectal cancer with liver metastases (TanyNanyM1), and the liver metastases are unresectable; or histologically or cytologically confirmed IVb phase of esophageal squamous cell carcinoma with liver metastases (TanyNanyM1) (excluding mixed type adenosquamous carcinoma), and the liver metastases are unresectable; or histologically or cytologically confirmed other gastrointestinal tumors with liver metastases (excluding gastrointestinal stromal tumors, neuroendocrine tumors and other malignant tumors of non-glandular epithelial origin), and the liver metastases are unresectable; 4. No previous systemic treatment, including chemotherapy, targeted and immunotherapy; those who have received neoadjuvant (radiotherapy) chemotherapy and radical surgery for recurrence more than 6 months, and those who recur more than 6 months after adjuvant (radiotherapy) chemotherapy or radical concurrent chemoradiotherapy; 5. The target lesion must contain liver metastases. According to RECIST version 1.1, liver metastases have at least one measurable focus; 6. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should > 2 weeks; 7. ECOG PS score 0-1; 8. Expected survival time more than 3 months; 9. The main organs are functioning normally.
Exclusion criteria
Exclusion criteria: 1. Patients with active bleeding within 2 months of primary and/or metastatic lesions; 2. Patients with previous arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack), deep venous thrombosis or pulmonary embolism; 3. Patients who are receiving thrombolytic or anticoagulant therapies such as warfarin, heparin, or their analogists; allowed to take low-dose heparin (6000 to 12,000 U/d for adults) or low-dose aspirin (= 150 mmHg, Diastolic BP >= 100 mmHg); or taking two or more antihypertensive drugs to control blood pressure; acute myocardial infarction, malignant arrhythmias (including QT interval > 450 ms in men and > 470 ms in women) and >= 2 grade congestive heart failure (NYHA grade); active or uncontrolled severe infection (NCI-CTC AE grade >= 2 infection); liver diseases such as cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis (HBV-DNA > 1000 IU/mL) require antiviral therapy; diabetic patients with poor blood glucose control (fasting blood glucose > 10 mmol/L); routine urine indicated urine protein >= ++, and confirmed 24-hour urine protein quantitative > 1.0 g; 10. Clinically significant ascites, including any ascites that can be found on a physical examination, ascites that has been treated or currently in need of treatment, and only those with a small amount of ascites but no symptoms can be selected; 11. A moderate amount of fluid in both sides of the chest, or a large amount of fluid in one side of the chest, or has caused respiratory dysfunction Patient to be drained; 12. Uncontrolled metabolic disorders or other non-malignant organs or secondary reactions to systemic diseases or cancers that may lead to higher medical risk and/or uncertainty in survival evaluation; 13. Known to have active tuberculosis; 14. Suffering from interstitial lung disease requiring steroid therapy; 15. Significantly malnourished patients; 16. Those who have a history of psychotropic substance abuse and are unable to quit or have a mental disorder; 17. Known to be allergic to the test drug; 18. Pregnant or lactating women; 19. Participated in clinical trials of other anti-tumor therapies within 4 weeks; 20. History of other primary malignancies, but the following:(1) complete remission of malignant tumors for at least 2 years prior to enrollment and no additional treatment during the study; (2) non-melanoma skin cancer or malignant freckle-like sputum with adequate treatment and no evidence of disease recurrence; (3) adequately treated and in-situ carcinoma without evidence of disease recurrence; 21. Ac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Duration of Response ;Overall Survival;Disease Control Rate;Conversion Rate of Liver Metastases ; | — |
Countries
China
Contacts
Public ContactZhang Jun
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed