Colorectal Cancer
Conditions
Interventions
Experimental group:Camrelizumab (200mg,IV,D1,Q3W) Combined with Fruquintinib (5 mg, PO, QD, D1-14, Q3W) and Sodium Propionate Capsules (1 g, PO, TID, D1-D21, Q3W)
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily enrolled in this study, provided written informed consent, demonstrated good compliance, and are able to comply with follow-up procedures; 2.Aged 18 ~70 years, regardless of gender (calculated as of the date of informed consent signing); 3.Patients with pathologically confirmed advanced colorectal carcinoma (all other histological subtypes are excluded); 4.Documented disease progression or intolerance following >= 2 prior lines of systemic anticancer therapy (including, but not limited to, regimens containing fluorouracil, irinotecan, or oxaliplatin); 5.At least one measurable target lesion as defined by RECIST v1.1; 6.ECOG PS 0~1; 7.MSS or MSI-L/pMMR status; 8.Life expectancy >= 3 months; 9.Normal major organ functions.
Exclusion criteria
Exclusion criteria: 1.History of other active malignancies within the past 3 years or concurrent malignancy (with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 2.Participation in any other interventional clinical trial within 4 weeks prior to enrollment; 3.Previously received anti-vascular small-molecule targeted drug therapy, such as Regofenib, etc. (excluding large-molecule targeted drug therapy, such as bevacizumab, etc.); 4.Previously received immunosuppressive therapy, such as PD-1 monoclonal antibody and CTLA-4 monoclonal antibody; 5.History of severe intolerance to fruquintinib or camrelizumab (i.e., grade 4 toxicity of one of the drugs; Class 3-4 toxicity of other co-administered drugs is not excluded); 6.Symptomatic brain or meningeal metastases (except those with brain metastases that have undergone local radiotherapy or surgery for more than 6 months and whose disease control is stable); 7.Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding within 3 months > 30mL, hematemesis, black feces, blood in the stool), hemoptysis (within 4 weeks > 5mL fresh blood), etc. Or treatment of venous/venous thrombosis events occurring within the preceding 6 months; 8.Urine routine indicated urinary protein >= 2+ and 24-hour urinary protein quantification > 1.0 g; 9.Known interstitial lung disease, with the exception of radiologically detected interstitial changes only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate,DCR;During of response,DoR;Progression-free survival,PFS;Overall survival,OS; | — |
Countries
China
Contacts
Public ContactQiu Wengsheng
The Affiliated Hospital of Qingdao University
Outcome results
None listed