Colorectal Cancer, Immunotherapy
Conditions
Brief summary
To evaluate the clinical efficacy and safety of TAS-102 combined with bevacizumab and tislelizumab in third-line or above treatment in patients with advanced colorectal adenocarcinoma with liver metastasis.
Interventions
DRUGTislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
DRUGbevacizumab
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks
DRUGTAS-102
Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks
Sponsors
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who provided informed consent and voluntarily enrolled * Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology; * 18-75 years old; * Measurable target lesions according to RECIST V1.1 assessment criteria; * Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil); * 0 \ 2 points according to ECOG quality of life score; * Drugs can be taken orally * Estimated survival ≥3 months; * Women of childbearing age should comply with contraceptive measures if pregnancy test is negative; * Ascites with no obvious symptoms and no clinical intervention; * Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy; * Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.
Exclusion criteria
* Previous application of TAS-102; * Pregnant or lactating women; * No contraception during the reproductive period; * patients known to have a history of allergy to any study drug, similar drug or excipient; * Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction; * Patients with a history of thromboembolism, except those caused by PICC; * Patients with active infection; * Patients with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90) MmHg); * Patients with brain metastases with clinical symptoms or imaging evidence; * Contraindications for treatment of other chronic diseases; * Previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, kidney Inflammation and other conditions, the current AE is still ≥2; * According to THE NCI CTCAE 5.0 assessment criteria, there are all types of existing cases due to previous treatment Patients with grade ≥2 toxic reactions; * Other conditions that the investigator determines are not suitable for inclusion in the study. * Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| progression free survival | up to 24 months | Time from enrollment to the onset of disease progression or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | every 8 weeks (up to 24 months) | Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | every 3 months (up to 24 months) ] | Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up. |
Countries
China
Contacts
Primary ContactYang jian wei, bachelor
Outcome results
None listed