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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05314101
• Other study ID #: TBT001
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2022
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2022
• Source: Fujian Cancer Hospital
• Contact: Yang jian wei, bachelor
• Phone: 13805097959
• Email: swzcq62[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Immunotherapy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	FujianCH	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival (OS)	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.	every 3 months (up to 24 months) ]
Primary	progression free survival	Time from enrollment to the onset of disease progression or death.	up to 24 months
Secondary	Objective Response Rate (ORR)	Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor	every 8 weeks (up to 24 months)