Stage IV colorectal cancer
Conditions
Interventions
Experimental group:Approved Products - Pharmaceuticals
Sponsors
Yantai Yuhuangding Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age greater than or equal to 18 years old. 2. histologically or cytologically confirmed stage IV colorectal cancer (International Union Against Cancer 8th edition colorectal cancer staging). 3. Adequate bone marrow, hepatic, renal and coagulation functions according to protocol-required laboratory evaluations. 4. Subjects must have progressed on first- and second-line standard anti-tumour therapy (chemotherapeutic agents including fluorouracil, oxaliplatin and irinotecan) and are permitted to have received previous neoadjuvant or adjuvant pelvic regional radiotherapy. 5. Subjects who have withdrawn from standard therapy due to unacceptable toxicity, ensuring that treatment was stopped before disease progression and excluding the use of the same drug in therapy, are also permitted to be included in the study. 6. Tumour tissue mismatch repair (pMMR) by immunohistochemistry (IHC) and tumour tissue microsatellite stability (MSS) by polymerase chain reaction (PCR). 7Subjects had at least one independent imaging measurable lesion according to RECIST 1.1 Criteria for Evaluation of Efficacy in Solid Tumours. 8ECOG score of 0-1. 9.Expected survival time >= 24 weeks. 10. Bone marrow, liver and kidney organ function and coagulation laboratory tests within 7 days prior to the first dose meet the study requirements (no transfusion of blood, blood products, or correction with granulocyte colony-stimulating factor or other haematopoietic stimulating factor within 7 days prior to laboratory tests). 11. Females of childbearing potential must have had a negative blood pregnancy test within 7 days prior to the first dose. Male or female patients of childbearing potential voluntarily use an effective method of contraception, such as a double barrier method of contraception, condoms, oral or injectable contraceptives, intrauterine devices, and abstinence for the duration of the study and for 6 months after the last study dose. All female patients will be considered of childbearing potential unless the female patient is naturally menopausal, has undergone artificial menopause or sterilisation (hysterectomy, bilateral adnexectomy). 12. Voluntary enrolment and signed informed consent to follow the trial treatment protocol and visit schedule.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to recombinant humanised anti-PD-1 monoclonal antibody drugs and their components. 2. Hypertension not stably controlled by medication, defined as: systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg. 3. Patients with current gastrointestinal diseases such as active gastric and duodenal ulcers, ulcerative colitis, or active bleeding from unresected tumours, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator; or previous gastrointestinal perforation or gastrointestinal fistula, which has not been healed after surgical treatment. 4. Patients with a history of arterial thrombosis or deep vein thrombosis within 6 months prior to enrolment, or with evidence or history of bleeding tendency, regardless of severity, within 2 months prior to enrolment. 5. Stroke event or transient ischaemic attack within 12 months prior to enrolment. 6. Cardiac disease including congestive heart failure, acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrolment; or patients with cardiac insufficiency of NYHA class 2 or higher; left ventricular ejection fraction (LVEF) =1×10^4/ml); known hepatitis C virus infection (HCV) with positive HCV RNA (>=1×10^3/ml), or cirrhosis. 13. Pregnant or breastfeeding women or women with potential for pregnancy who have a positive pregnancy test prior to the first dose; or female participants themselves and their partners who are unwilling to use strict contraception during the study. 14. Presence of serious psychological or psychiatric abnormalities. 15. Any clinical or laboratory abnormality or compliance problem that, in the opinion of the investigator, makes the participant unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate;Objective response rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJian Chen
Yantai Yuhuangding Hospital
Outcome results
None listed