Clinical trial · Interventional
TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer
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
NCT05314101CI-TRIAL-00060503unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Immunotherapy | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| TAS-102 | Drug | — | UNRESOLVED |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAS-102 combined with bevacizumab and tislelizumab
- description
- TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer
- interventionNames
- Drug: Tislelizumab
- Drug: bevacizumab
- Drug: TAS-102
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- up to 24 months
- description
- Time from enrollment to the onset of disease progression or death.
Secondary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.