Back to resultsTAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
Primary Purpose
Immunotherapy, Colorectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
bevacizumab
TAS-102
Sponsored by
About this trial
This is an interventional treatment trial for Immunotherapy
Eligibility Criteria
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.
Sites / Locations
- FujianCHRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAS-102 combined with bevacizumab and tislelizumab
Arm Description
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
Outcomes
Primary Outcome Measures
progression free survival
Time from enrollment to the onset of disease progression or death.
Secondary Outcome Measures
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05314101
Brief Title
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
Official Title
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer : An Open-label 、Phase Ⅱ Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunotherapy, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAS-102 combined with bevacizumab and tislelizumab
Arm Type
Experimental
Arm Description
TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks
Intervention Type
Drug
Intervention Name(s)
TAS-102
Intervention Description
Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks
Primary Outcome Measure Information:
Title
progression free survival
Description
Time from enrollment to the onset of disease progression or death.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time Frame
every 8 weeks (up to 24 months)
Other Pre-specified Outcome Measures:
Title
Overall survival (OS)
Description
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.
Time Frame
every 3 months (up to 24 months) ]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang jian wei, bachelor
Phone
13805097959
Ext
86
Email
swzcq62@163.com
Facility Information:
Facility Name
FujianCH
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang jian wei
Phone
13805097959
Email
swzcq62@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
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