Advanced colorectal cancer
Conditions
Interventions
Experimental Group (Anlotinib plus Sintilimab):Anlotinib plus Sintilimab
Sponsors
The Second Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients with advanced colorectal adenocarcinoma confirmed by histology or cytology; 2.Patients without liver metastases who have explicitly refused chemotherapy; 3.Patients who have not received systematic therapy or have developed metastasis or recurrence more than 12 months after the completion of adjuvant therapy; 4.The patient has at least one measurable lesion (per RECIST 1.1 criteria); 5.Patients who have undergone local radiotherapy at least 3 weeks prior to initial drug therapy are eligible for enrollment; however, RECIST-evaluated lesions must not be within the radiotherapy field; 6.The patient must be at least 18 years of age; 7.Physical condition: ECOG score 0-1; 8.Life expectancy >=12 weeks; 9.The patient must have the capacity to understand and voluntarily sign a written informed consent form; 10.Women of childbearing age must have a negative pregnancy test result within 7 days prior to initiating treatment. Both the patient and their spouse must use contraception during the study period;
Exclusion criteria
Exclusion criteria: 1.Patients who underwent major surgery or sustained severe trauma within 4 weeks prior to the initial medication administration; 2.Patients with hypersensitivity to any component of the study protocol; 3.Patients planning for pregnancy or already pregnant; 4.Patients with brain metastases who cannot accurately describe their condition; 5.Patients with autoimmune diseases or organ transplants; 6.Received immunosuppressive therapy within 2 weeks prior to treatment initiation (excluding inhaled corticosteroids or prednisone 1.5 times the upper limit of normal Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)>2.5 times the upper limit of normal; -Creatinine>1.5 times the upper limit of normal; 11.Patients with other cancers (excluding advanced colorectal cancer) within five years prior to the initiation of treatment in this study. Exclusions include cervical carcinoma in situ, cured basal cell carcinoma, and bladder epithelial tumors. 12.Patients with operable colorectal cancer (those who explicitly refuse surgery or are unsuitable for surgery may be enrolled); 13.History of drug abuse, substance use, or alcohol dependence; 14.Lack of legal capacity or limited civil capacity; 15.Other circumstances deemed unsuitable for enrollment by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Deepness of response, DpR;Progression-free survival, PFS;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactZang Yuansheng
The Second Affiliated Hospital of Naval Medical University
Outcome results
None listed