Colorectal cancer
Conditions
Interventions
Single arm:camrelizumab combined with famitinib
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 75 years, male or female; 2. Patients with histologically or cytologically confirmed colorectal cancer, at least one evaluable or measurable lesions as per RECIST version 1.1; 3. Patients who had previously progressed after receiving standard second-line advanced treatment; 4. ECOG performance status 0 - 1; 5. Life expectancy of at least 12 weeks; 6. Other antiangiogenic drugs such as cetuximab and bevacizanam were not excluded; 7. Patients with adequate organ function at the time of enrollment as defined below: (1) Blood routine examination standard: Hb >= 90g/L (without blood transfusion within 14 days before enrollment); ANC >= 1.5 x 10^9/L; PLT >= 80 x 10^9/L; (2) Biochemical examination shall meet the following standards: ALB >= 30g/L (without ALB transfusion within 14 days before enrollment); ALT and AST = 60ml/min; 8. UCG: LVEF >= 50%; 9. Subjects voluntarily joined the study, signed informed consent, good compliance, and followed up. 10. Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period.
Exclusion criteria
Exclusion criteria: 1. Patients with allergic to treatment drugs; 2. GradeICHD or arrhythmia (including QTc lengthen > Male, 450 ms or Female, 470ms; 3. Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: active digestive ulcer lesions, fecal occult blood (++), nausea and hematemesis within 2 months Medical history; 4. Coagulation abnormalities: INR >1.5, APTT >1.5ULN; 5. A variety of factors that affect oral drug absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 6. Patients with symptomatic brain metastasis; 7. Women who are pregnant or breastfeeding; 8. Except for other malignant tumors, basal cell carcinoma of the skin and cervical cancer in situ in the past 5 years; 9. With a history of psychiatric substance abuse who cannot quit or has a mental disorder; 10. Patients participated in clinical trials of other drugs within 4 weeks; 11. Patients with unhealed wounds, unhealed ulcers or unhealed fractures; 12. Thyroid dysfunction; 13. Urine protein >= ++ or confirmed 24 hour urine protein concentration; 14. Patients who have undergone systemic chemotherapy, radiotherapy, surgery, hormone therapy, or immunotherapy = 160mmHg and diastolic blood pressure >= 100mmHg) despite treatment with several hypotensive agents; 18. Patients with acute coronary syndrome (including myocardial infarction and unstable angina) and a history of coronary angioplasty or stent implantation within 6 months prior to inclusion; 19. Acute or chronic active hepatitis B or hepatitis C; 20. Women who are pregnant or breastfeeding; 21. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Recurrence-Free Survival;Disease Control Rate;Quality of Life;Drug Safety; | — |
Countries
China
Contacts
Public ContactHong Zong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed