Colorectal cancer
Conditions
Interventions
group:Adebrelimab + apatinib
Sponsors
Changzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. =18 years old, gender not limited; 2. Subjects with advanced colorectal cancer confirmed by pathology; 3. Previously received first-line standard treatment but failed. The definition of "treatment failure" : (1) There is clear imaging or clinical evidence of disease progression during the treatment process or within 3 months after the last treatment; (2) For subjects who withdraw from standard treatment due to intolerable adverse events of chemotherapy, according to the CTCAE 5.0 standard, the severity level of the intolerant hematological adverse event should reach grade IV or above (platelet count decrease to grade III or above), or the severity level of the non-hematological adverse event should reach grade III or above. Moreover, the researchers determined that the subject still could not tolerate repeated treatment with the original plan. Note: 1) If disease progression occurs during or within =6 months after the completion of adjuvant therapy, it is considered that the adjuvant therapy is the first-line treatment for advanced diseases. 2) The allowed early treatment is chemotherapy combined with monoclonal antibody drugs (bevacizumab, cetuximab, panitumab, aflibercept, etc.). 4. According to the RECIST 1.1 standard, the subject has at least one measurable target lesion; 5. ECOG score: 0 to 1 point; 6. Expected survival period =3 months; 7. The main organ functions are good, that is, the relevant examination indicators meet the following requirements within 14 days before enrollment: (1) Blood routine test (no blood transfusion and no drugs for increasing white blood count or platelet count within 14 days before screening) : Hemoglobin > 90 g/L; Neutrophil count > 1.5×109/L; Platelet count > 100×109/L; (2) Biochemical test: Total bilirubin = 1.5×ULN (upper limit of normal value); Blood alanine aminotransferase (ALT) and blood aspartate aminotransferase (AST) = 2×ULN; If there is liver metastasis, ALT and AST should be = 5×ULN. Endogenous creatinine clearance rate = 60 ml/min (Cockcroft-Gault formula); (3) Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) = 50%; 8. If there is hepatitis B virus (HBV) infection, such as positive HBsAg, HBV-DNA testing is required, and HBV-DNA should be less than 2000 IU/mL (if the research center only has a copy/mL testing unit, it must be less than 104 copy/mL). For subjects with HBV-DNA=2000 IU/mL, they received antiviral treatment for at least one week before the first administration (only nucleoside drugs such as entecavir, tenofovir fumarate disoproxil, and tenofovir profol fumarate tablets were allowed), and the viral copy number decreased by more than 10 times (1 lg) compared to before the first administration. For HBV-infected individuals, antiviral treatment must be received throughout the study period. Subjects positive for hepatitis C virus (HCV) -RNA must receive antiviral treatment in accordance with the treatment guidelines; 9.Women of childbearing age must have a negative (ßHCG) pregnancy test within 3 days before their first medication.
Exclusion criteria
Exclusion criteria: 1. Previously or concurrently suffering from other malignant tumors, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ; 2. Subjects who have previously received ICS treatment (such as PD-1/PD-L1 inhibitors, CTLA-4 inhibitors); Have participated in other drug clinical trials within 3 to 4 weeks; 4. For those who have not recovered from damage caused by other treatments, where the interval between receiving nitrosamines or mitomycin is =6 weeks from taking the study drug; Have received other cytotoxic drugs, targeted drugs, radiotherapy or surgery for =4 weeks, and the wound has completely healed; Have received Chinese patent medicine or traditional Chinese medicine for at least 2 weeks; 5. There are multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 6. A history of bleeding, with any severe bleeding event reaching grade 3 or above in CTCAE 5.0 within 4 weeks prior to screening; 7. Subjects who were known to have central nervous system metastases or a history of central nervous system metastases before screening. For subjects with clinically suspected central nervous system metastases, enhanced CT or enhanced Magnetic Resonance Imaging (MRI) examinations must be conducted within 28 days before enrollment to rule out central nervous system metastases. 8. Individuals with hypertension who have not achieved good control with a single antihypertensive drug (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Those with a history of unstable angina pectoris; Those who were newly diagnosed with angina pectoris within 3 months before screening or had a myocardial infarction event within 6 months before screening; Arrhythmia (including QTcF: = 450 ms in men and = 470 ms in women) requires long-term use of antiarrhythmic drugs and a New York Heart Association grade of = II heart failure. 9. Urine routine test indicates urine protein = ++ and confirms 24-hour urine protein quantification > 1.0g; 10. Suffering from active infection, having an unexplained fever of = 38.5? within 7 days before the first medication, or a white blood cell count of > 15×109/L at the baseline period; 11. Previous or current interstitial pneumonia/interstitial lung disease, pneumonia requiring systemic treatment with glucocorticoids; Those who currently have active pneumonia or have been confirmed by pulmonary function tests to have severe impaired lung function; 12. Long-term unhealed wounds or incompletely healed fractures; 13. The imaging shows that the tumor has invaded the area around important blood vessels or the researcher determines that the tumor of the subject has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage; 14. Patients with abnormal coagulation function and bleeding tendency (the INR must be within the normal range without the use of anticoagulants 14 days before enrollment); Subjects treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; On the premise that the International Normalized Ratio (INR) of prothrombin time is = 1.5, low-dose warfarin (1 mg orally once daily) or low-dose aspirin (daily dosage not exceeding 100 mg) is allowed for preventive purposes. 15. Events of active or venous thrombosis that occurred within one year prior to screening, such as cerebrovascular accidents (including transient isc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease control rate;Adverse event; | — |
Countries
China
Contacts
Public ContactWenwei Hu
Changzhou First People's Hospital
Outcome results
None listed