TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
NCT ID: NCT05314101
Last Updated: 2022-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2022-04-01
2024-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAS-102 combined with bevacizumab and tislelizumab
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
Tislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
bevacizumab
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks
TAS-102
Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks
Interventions
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Tislelizumab
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
bevacizumab
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks
TAS-102
Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Cancer Hospital
OTHER_GOV
Responsible Party
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Locations
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FujianCH
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TBT001
Identifier Type: -
Identifier Source: org_study_id
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