NCT05314101

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

August 23, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

March 19, 2022

Last Update Submit

August 19, 2022

Conditions

ImmunotherapyColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival

    Time from enrollment to the onset of disease progression or death.

    up to 24 months

Secondary Outcomes (1)

  • Objective Response Rate (ORR)

    every 8 weeks (up to 24 months)

Other Outcomes (1)

  • Overall survival (OS)

    every 3 months (up to 24 months) ]

Study Arms (1)

TAS-102 combined with bevacizumab and tislelizumab

EXPERIMENTAL

TAS-102 combined with bevacizumab and tislelizumab third-line or above in the treatment of liver metastasis in colorectal cancer

Drug: TislelizumabDrug: bevacizumabDrug: TAS-102

Interventions

TislelizumabDRUG

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

TAS-102 combined with bevacizumab and tislelizumab
bevacizumabDRUG

Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 and day 15 of every 4 weeks

TAS-102 combined with bevacizumab and tislelizumab
TAS-102DRUG

Participants will receive TAS-102, 35mg/m2, bid，d1-d5, d8-d12 of every 4 weeks

TAS-102 combined with bevacizumab and tislelizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who provided informed consent and voluntarily enrolled
  • Patients with liver metastasis of advanced colorectal adenocarcinoma with MSS confirmed by pathology;
  • years old;
  • Measurable target lesions according to RECIST V1.1 assessment criteria;
  • Progression after standard second-line treatment (irinotecan, oxaliplatin, or fluorouracil);
  • \~ 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.

You may not qualify if:

  • 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;
  • Received any anti-tumor therapy and participated in other clinical studies within 4 weeks prior to enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FujianCH

Fuzhou, Fujian, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

tislelizumabBevacizumabtrifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yang jian wei, bachelor

CONTACT

13805097959swzcq62@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2022

First Posted

April 6, 2022

Study Start

April 1, 2022

Primary Completion

February 28, 2023

Study Completion

February 28, 2024

Last Updated

August 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)