colorectal liver metastases
Conditions
Interventions
Treatment group:TACE combined with apatinib
Sponsors
Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Mesdicne
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. male or female patient aged 18-80 years old; 2. Histologically confirmed colorectal adenocarcinoma; 3. Patients had been treated with = 2 standard chemotherapy (fluorouracil, irinotecan and oxaliplatin) and failedTreatment failure means: (1) disease progress during the treatment or disease progress in 3 months after the treatment, clear imaging or clinical evidence of progress; (2) patients who cannt tolerate adverse events and exit the standard treatment. Note: 1) The treatment of each line of progressive disease includes one or more drugs with a duration of administration of 1 or more cycles or longer; 2) If the disease progress occurs during or after completion of adjuvant therapy / neoadjuvant treatment, the treatment is considered to be a first-line treatment failure for progressive disease; 3) pre-treatment includes chemotherapy combined with monoclonal antibody (bevacizumab, cetuximab, pani monoclonal antibody, aflibercept); 4. According to the RECIST 1.1: the patients have at least one diameter measurable liver metastatic target lesion (CT scan with a length =10 mm, a lymph node lesion CT scan diameter =15 mm, and a scan layer thickness of no more than 5 mm; without local treatment); 5. ECOG performance status 0-2 6. Expected survival = 3 months; 7. The main organ function well, 14 days before enrollment l, the relevant test indicators should meet the following requirements: a) blood routine examination: (1) Hemoglobin = 90 g/L (14 days without blood transfusion); (2) Neutrophil count> 1.5 × 10^9/L; total bilirubin = 1.5 × ULN (normal upper limit); Serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) =5 × ULN; (3) Endogenous creatinine clearance = 60 m /min (Cockcroft-Gault formula); Child-Pugh liver function rating: Grade A or better grade B (=7 points); 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, should be sterilized for surgery, or agreed to use the appropriate method for contraception at the 8 weeks after the trial and at the end of the last test; 9. Subjects volunteer to join the study, signed informed consent, good compliance, agree with follow-up.;Inclusion criteria: 1. male or female patient aged 18-80 years old; 2. Histologically confirmed colorectal adenocarcinoma; 3. Patients had been treated with = 2 standard chemotherapy (fluorouracil, irinotecan and oxaliplatin) and failedTreatment failure means: (1) disease progress during the treatment or disease progress in 3 months after the treatment, clear imaging or clinical evidence of progress; (2) patients who cannt tolerate adverse events and exit the standard treatment. Note: 1) The treatment of each line of progressive disease includes one or more drugs with a duration of administration of 1 or more cycles or longer; 2) If the disease progress occurs during or after completion of adjuvant therapy / neoadjuvant treatment, the treatment is considered to be a first-line treatment failure for progressive disease; 3) pre-treatment includes chemotherapy combined with monoclonal antibody (bevacizumab, cetuximab, pani monoclonal antibody, aflibercept); 4. According to the RECIST 1.1: the patients have at least one diameter measurable liver metastatic target lesion (CT scan with a length =10 mm, a lymph node lesion CT scan diameter =15 mm, and a scan layer thickness of no more than 5 mm; without local treatment); 5. ECOG performance status 0-2 6. Expected survival = 3 months; 7. The main organ function well, 14 days before enrollment l, the relevant test indicators should meet the following requirements: a) blood routine examination: (1) Hemoglobin = 90 g/L (14 days without blood transfusion); (2) Neutrophil count> 1.5 × 10^9/L; total bilirubin = 1.5 × ULN (normal upper limit); Serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) =5 × ULN; (3) Endogenous creatinine clearance = 60 m /min (Cockcroft-Gault formula); Child-Pugh liver function rating: Grade A or better grade B (=7 points); 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, should be sterilized for surgery, or agreed to use the appropriate method for contraception at the 8 weeks after the trial and at the end of the last test; 9. Subjects volunteer to join the study, signed informed consent, good compliance, agree with follow-up.;Inclusion criteria: 1. male or female patient aged 18-80 years old; 2. Histologically confirmed colorectal adenocarcinoma; 3. Patients had been treated with = 2 standard chemotherapy (fluorouracil, irinotecan and oxaliplatin) and failedTreatment failure means: (1) disease progress during the treatment or disease progress in 3 months after the treatment, clear imaging or clinical evidence of progress; (2) patients who cannt tolerate adverse events and exit the standard treatment. Note: 1) The treatment of each line of progressive disease includes one or more drugs with a duration of administration of 1 or more cycles or longer; 2) If the disease progress occurs during or after completion of adjuvant therapy / neoadjuvant treatment, the treatment is considered to be a first-line treatment failure for progressive disease; 3) pre-treatment includes chemotherapy combined with monoclonal antibody (bevacizumab, cetuximab, pani monoclonal antibody, aflibercept); 4. According to the RECIST 1.1: the patients have at least one diameter measurable liver metastatic target lesion (CT scan with a length =10 mm, a lymph node lesion CT scan diameter =15 mm, and a scan layer thickness of no more than 5 mm; without local treatment); 5. ECOG performance status 0-2 6. Expected survival = 3 months; 7. The main organ function well, 14 days before enrollment l, the relevant test indicators should meet the following requirements: a) blood routine examination: (1) Hemoglobin = 90 g/L (14 days without blood transfusion); (2) Neutrophil count> 1.5 × 10^9/L; total bilirubin = 1.5 × ULN (normal upper limit); Serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) =5 × ULN; (3) Endogenous creatinine clearance = 60 m /min (Cockcroft-Gault formula); Child-Pugh liver function rating: Grade A or better grade B (=7 points); 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, should be sterilized for surgery, or agreed to use the appropriate method for contraception at the 8 weeks after the trial and at the end of the last test; 9. Subjects volunteer to join the study, signed informed consent, good compliance, agree with follow-up.;Inclusion criteria: 1. male or female patient aged 18-80 years old; 2. Histologically confirmed colorectal adenocarcinoma; 3. Patients had been treated with = 2 standard chemotherapy (fluorouracil, irinotecan and oxaliplatin) and failedTreatment failure means: (1) disease progress during the treatment or disease progress in 3 months after the treatment, clear imaging or clinical evidence of progress; (2) patients who cannt tolerate adverse events and exit the standard treatment. Note: 1) The treatment of each line of progressive disease includes one or more drugs with a duration of administration of 1 or more cycles or longer; 2) If the disease progress occurs during or after completion of adjuvant therapy / neoadjuvant treatment, the treatment is considered to be a first-line treatment failure for progressive disease; 3) pre-treatment includes chemotherapy combined with monoclonal antibody (bevacizumab, cetuximab, pani monoclonal antibody, aflibercept); 4. According to the RECIST 1.1: the patients have at least one diameter measurable liver metastatic target lesion (CT scan with a length =10 mm, a lymph node lesion CT scan diameter =15 mm, and a scan layer thickness of no more than 5 mm; without local treatment); 5. ECOG performance status 0-2 6. Expected survival = 3 months; 7. The main organ function well, 14 days before enrollment l, the relevant test indicators should meet the following requirements: a) blood routine examination: (1) Hemoglobin = 90 g/L (14 days without blood transfusion); (2) Neutrophil count> 1.5 × 10^9/L; total bilirubin = 1.5 × ULN (normal upper limit); Serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) =5 × ULN; (3) Endogenous creatinine clearance = 60 m /min (Cockcroft-Gault formula); Child-Pugh liver function rating: Grade A or better grade B (=7 points); 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, should be sterilized for surgery, or agreed to use the appropriate method for contraception at the 8 weeks after the trial and at the end of the last test; 9. Subjects volunteer to join the study, signed informed consent, good compliance, agree with follow-up.;Inclusion criteria: 1. male or female patient aged 18-80 years old; 2. Histologically confirmed colorectal adenocarcinoma; 3. Patients had been treated with = 2 standard chemotherapy (fluorouracil, irinotecan and oxaliplatin) and failedTreatment failure means: (1) disease progress during the treatment or disease progress in 3 months after the treatment, clear imaging or clinical evidence of progress; (2) patients who cannt tolerate adverse events and exit the standard treatment. Note: 1) The treatment of each line of progressive disease includes one or more drugs with a duration of administration of 1 or more cycles or longer; 2) If the disease progress occurs during or after completion of adjuvant therapy / neoadjuvant treatment, the treatment is considered to be a first-line treatment failure for progressive disease; 3) pre-treatment includes chemotherapy combined with monoclonal antibody (bevacizumab, cetuximab, pani monoclonal antibody, aflibercept); 4. According to the RECIST 1.1: the patients have at least one diameter measurable liver metastatic target lesion (CT scan with a length =10 mm, a lymph node lesion CT scan diameter =15 mm, and a scan layer thickness of no more than 5 mm; without local treatment); 5. ECOG performance status 0-2 6. Expected survival = 3 months; 7. The main organ function well, 14 days before enrollment l, the relevant test indicators should meet the following requirements: a) blood routine examination: (1) Hemoglobin = 90 g/L (14 days without blood transfusion); (2) Neutrophil count> 1.5 × 10^9/L; total bilirubin = 1.5 × ULN (normal upper limit); Serum alanine aminotransferase (ALT) or aspartate aminotransferase AST) =5 × ULN; (3) Endogenous creatinine clearance = 60 m /min (Cockcroft-Gault formula); Child-Pugh liver function rating: Grade A or better grade B (=7 points); 8. Women of childbearing age must undergo a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test. For men, should be sterilized for surgery, or agreed to use the appropriate method for contraception at the 8 weeks after the trial and at the end of the last test; 9. Subjects volunteer to join the study, signed informed consent, good compliance, agree with follow-up.
Exclusion criteria
Exclusion criteria: 1. Any local treatment other than TACE (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to participating in the study; 2. In the past (5 years) or at the same time suffering from other untreated malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer; 3. (Systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with high blood pressure and can not be reduced to normal range by antihypertensive therapy; 4. more than grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent male = 450 ms, female =470 ms); 5. According to NYHA standard III-IV grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Central nervous system metastases or known brain metastases have occurred; 11. Past and present patients with pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients; 12. Urine routine display of urine protein = ++ or confirmed 24 hours urine protein> 1.0 g; 13. Allergy to study drug.;Exclusion criteria: 1. Any local treatment other than TACE (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to participating in the study; 2. In the past (5 years) or at the same time suffering from other untreated malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer; 3. (Systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with high blood pressure and can not be reduced to normal range by antihypertensive therapy; 4. more than grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent male = 450 ms, female =470 ms); 5. According to NYHA standard III-IV grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Central nervous system metastases or known brain metastases have occurred; 11. Past and present patients with pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients; 12. Urine routine display of urine protein = ++ or confirmed 24 hours urine protein> 1.0 g; 13. Allergy to study drug.;Exclusion criteria: 1. Any local treatment other than TACE (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to participating in the study; 2. In the past (5 years) or at the same time suffering from other untreated malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer; 3. (Systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with high blood pressure and can not be reduced to normal range by antihypertensive therapy; 4. more than grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent male = 450 ms, female =470 ms); 5. According to NYHA standard III-IV grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Central nervous system metastases or known brain metastases have occurred; 11. Past and present patients with pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients; 12. Urine routine display of urine protein = ++ or confirmed 24 hours urine protein> 1.0 g; 13. Allergy to study drug.;Exclusion criteria: 1. Any local treatment other than TACE (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to participating in the study; 2. In the past (5 years) or at the same time suffering from other untreated malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer; 3. (Systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with high blood pressure and can not be reduced to normal range by antihypertensive therapy; 4. more than grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent male = 450 ms, female =470 ms); 5. According to NYHA standard III-IV grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Central nervous system metastases or known brain metastases have occurred; 11. Past and present patients with pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients; 12. Urine routine display of urine protein = ++ or confirmed 24 hours urine protein> 1.0 g; 13. Allergy to study drug.;Exclusion criteria: 1. Any local treatment other than TACE (including but not limited to surgery, radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to participating in the study; 2. In the past (5 years) or at the same time suffering from other untreated malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer; 3. (Systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg) with high blood pressure and can not be reduced to normal range by antihypertensive therapy; 4. more than grade II myocardial ischemia or myocardial infarction, poor control of arrhythmia (including QTc intermittent male = 450 ms, female =470 ms); 5. According to NYHA standard III-IV grade cardiac insufficiency or cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 1.5 or prothrombin time (PT)> ULN + 4 seconds), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 10. Central nervous system metastases or known brain metastases have occurred; 11. Past and present patients with pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other patients; 12. Urine routine display of urine protein = ++ or confirmed 24 hours urine protein> 1.0 g; 13. Allergy to study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Disease Control Rate;objective remission rate; | — |
Countries
China
Contacts
Public ContactLIU YUJIN;LIU YUJIN;LIU YUJIN;LIU YUJIN;LIU YUJIN ;;;;
Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Mesdicne;Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Mesdicne;Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Mesdicne;Yueyang Hospital of integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Mesdicne;
Outcome results
None listed