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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Immunotherapy
• Intervention / Treatment: Drug: Tislelizumab; Drug: bevacizumab; Drug: TAS-102

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang jian wei, bachelor; Phone Number: 86 13805097959; Email: swzcq62@163.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • FujianCH
      • Contact: Yang jian wei; Phone Number: 13805097959; Email: swzcq62@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Tislelizumab; Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks; Drug: bevacizumab; Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks; Drug: TAS-102; Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression free survival	Time from enrollment to the onset of disease progression or death.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) ]

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): February 28, 2023
• Study Completion (Anticipated): February 28, 2024

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: TBT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No