Colorectal Neoplasms
Conditions
Brief summary
This is a single arm, open phase II study to evaluate the efficacy and safety of tislelizumab combined with cetuximab + irinotecan in the treatment of Ras wild-type recurrent and refractory colorectal cancer. This study will include Ras wild-type colorectal cancer that failed at least second-line treatment in the past, including chemotherapy (oxaliplatin, irinotecan, fluorouracil) with or without targeted drugs (cetuximab, bevacizumab). 33 patients were planned to be treated with tislelizumab combined with cetuximab + irinotecan every 2 weeks. The enrollment time is expected to be 12 months and the follow-up is 24 months.
Interventions
DRUGTEC
tislelizumab（an anti-PD-1 monoclonal antibody）+cetuximab（monoclonal antibody against EGFR）+irinotecan
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years； 2. The ECOG PS score of the eastern United States cancer cooperation group was 0 or 1; 3. Ras wild-type colorectal cancer diagnosed by histology and / or cytology has metastasis or recurrence that cannot be cured by surgery; 4. Have received at least second-line systemic anti-tumor treatment for MCRC and failed, in which chemotherapy drugs can include fluorouracil, oxaliplatin and irinotecan, such as XELOX, FOLFOX, FOLFIRI, folfoxiri and xeliri; targeted drugs can be combined or not, such as cetuximab and bevacizumab; 5. At least one measurable lesion defined according to RECIST version 1.1; 6. Patients with fertility must be willing to take efficient contraceptive measures during the study period and ≥ 120 days after the last administration of tirelizumab; female patients have negative urine or serum pregnancy test results ≤ 7 days before the first administration of the study drug; 7. Fully understand this study and voluntarily sign the informed consent form.
Exclusion criteria
1. The following laboratory indicators belong to the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 24 months after the last subject participating in | proportion of patients with complete and partial remission in the best efficacy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | 24 months after the last subject participating in | the best efficacy is the proportion of patients with complete remission, partial remission and stable disease |
| Progression free survival time (PFS） | 24 months after the last subject participating in | time from the start of medication to the initial progression of the disease |
| Overall survival (OS） | 36 months after the last subject participating in | time from the start of medication to death |
Other
| Measure | Time frame | Description |
|---|---|---|
| biomarker analysis | 12 months after the last subject participating in | PD-L1 expression, tumor mutation burden (TMB) and proteins in blood samples |
Countries
China
Outcome results
None listed