Image

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

Recruiting
18 - 75 years of age
Both
Phase 2

Powered by AI

Overview

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.

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.

Study details

Immunotherapy, Colorectal Cancer

NCT05314101

Fujian Cancer Hospital

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.