Colorectal cancer
Conditions
Interventions
single arm:camrelizumab combined with apatinib mesylate
Sponsors
The Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients, aged >= 18 years; 2. Patients with advanced or metastatic colorectal cancer confirmed by histology or cytology; 3. No serious liver and kidney damage, the functional level of the organ must meet the following requirements: ANC >= 1.5 * 10^9 / L; PLT >= 90 * 10^9 / L; Hb >= 90 g / L; TBIL = 50 mL / min (Cockcroft-Gault formula); LVEF >= 50%; Fridericia-corrected QT interval (QTcF) for males = 3 months; 7. The investigator evaluates that the patient can comply with the protocol requirements;8. Sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Patients who had received systemic chemotherapy, radiotherapy, surgery, hormone therapy or immunotherapy 2 weeks prior to inclusion; 2. Patients with a history of apatinib; 3. Patients with hypertension (systolic blood pressure >= 160 mmHg and diastolic blood pressure >= 90 mmHg) that are difficult to control despite the treatment with multiple antihypertensive drugs; 4. 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; 5. Patients with massive pleural effusion or ascites requiring drainage; 6. According to nci-ctcae version 5.0 >= 3 patients with active infection; 7. Symptomatic brain metastases; 8. Patients with partial or complete gastrointestinal obstruction; 9. Patients with interstitial pulmonary disease with symptoms or signs of activity; 10. Patients with allergic or hypersensitive constitution to treatment drugs or with autoimmune diseases; Has received allograft/solid organ transplantation; 11. Patients who require systemic corticosteroids (excluding temporary use for trials, prophylactic administration of anaphylaxis or reduction of radiation-related swelling) or immunosuppressants, or who have received such therapy less than 14 days prior to enrollment in this study; 12. Epileptic seizure patients requiring medication; 13. Patients who underwent major surgery (open-heart surgery or laparotomy, etc.), laparotomy biopsy, or trauma within 28 days prior to registration. Registration can be made on the same day of the week prior to 4 weeks (however, it should be made within 14 days prior to registration if an artificial anastomosis is performed without intestinal resection); 14. Patients with unhealed wounds, unhealed ulcers or unhealed fractures; 15. Patients with allergies to any study drug, similar drug or excipient; 16. Receive any other antineoplastic therapy, including antineoplastic Chinese patent medicines and immunopreparations; 17. Pregnant or nursing women who are fertile but refuse to use contraception; 18. Other circumstances that the investigator determined were not appropriate for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;DCR;AE; | — |
Countries
China
Contacts
Public ContactDong hua
The Affiliated Hospital of Jiangnan University
Outcome results
None listed