TAS-102 Combined With Bevacizumab and Tislelizumab Third-line or Above in the Treatment of Liver Metastasis in Colorectal Cancer

Fujian Provincial Cancer Hospital

Status and phase

Unknown

Phase 2

Conditions

Immunotherapy

Colorectal Cancer

Treatments

Drug: Tislelizumab

Drug: bevacizumab

Drug: TAS-102

Study type

Interventional

Funder types

Other

Identifiers

NCT05314101

TBT001

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.