Status:
UNKNOWN
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Immunotherapy
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 metas...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05314101
Start Date
April 1 2022
End Date
February 28 2024
Last Update
August 23 2022
Active Locations (1)
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1
FujianCH
Fuzhou, Fujian, China