Trifluridine/Tipiracil Combined With Oxaliplatin and Bevacizumab Versus XELOX Plus Bevacizumab in mCRC

Launched by TIANJIN MEDICAL UNIVERSITY CANCER INSTITUTE AND HOSPITAL · Oct 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment combinations for patients with advanced colorectal cancer who are starting treatment for the first time. One group of patients will receive a combination of trifluridine/tipiracil, oxaliplatin, and bevacizumab, while the other group will receive a standard treatment called XELOX along with bevacizumab. The goal is to see which treatment works better and is safer for patients. The trial will involve 184 participants, and they will be monitored closely with regular check-ups and imaging to track their health.

To qualify for the trial, participants must be at least 18 years old and have a confirmed diagnosis of colorectal cancer that has spread. They should not have received any prior chemotherapy for advanced cancer, and their overall health must meet specific criteria. Participants can expect to receive their assigned treatments for several cycles, with follow-ups every three months. Importantly, patients in the experimental group can receive the trifluridine/tipiracil treatment at no cost. This trial aims to gather more information on how these treatments can help improve outcomes for patients with advanced colorectal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed the informed consent.
• • 2. Age ≥18.
• • 3. Colonic adenocarcinoma confirmed histologically or histopathologically.
• • 4. No previous chemotherapy for advanced colorectal cancer, or patients who had received adjuvant chemotherapy after radical resection and relapsed 12 months after the completion of adjuvant chemotherapy.
• • 5. ECOG physical status score is 0 or 1.
• • 6. There are measurable metastatic lesions according to RECIST version 1.1.
• 7. Appropriate organ function according to the following laboratory test values obtained within 7 days prior to use on Day 1 of Cycle 1:
• • 1. Hemoglobin value ≥9.0g/dL.
• • 2. Absolute neutrophil count ≥1,500/mm3 (≥1.5\*109/L).
• • 3. Platelet count ≥100,000/mm3 (≥100\*109/L).
• • 4. Total serum bilirubin ≤1.5\* upper normal limit (ULN).
• • 5. Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5\* upper limit of normal value (ULN). If the abnormal liver function is due to liver metastasis, AST and ALT should be ≤5\*ULN.
• • 6. Serum creatinine ≤1.5 times \* upper limit of normal (ULN) or creatinine clearance ≥50ml/min.
• • 8. The results of urine or serum pregnancy test within 7 days prior to treatment were negative. Women who are likely to become pregnant and men must agree to take adequate contraceptive measures during the study period until 6 months after the end of medication.
• • 9. Survival is expected to be at least 3 months.
• • 10. Willing and able to follow research procedures and visit plans.
• Exclusion Criteria:
• 1. Has a serious illness or medical condition, including but not limited to the following:
• • 1. There are other active malignant tumors at the same time, excluding those that have not occurred for more than 5 years or carcinoma in situ that can be cured by adequate treatment.
• • 2. Known presence of brain metastases or leptomeningeal metastases.
• • 3. Systemic active infection (i.e., infection causes body temperature ≥38℃).
• • 4. Clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease.
• • 5. Uncontrolled diabetes.
• • 6. Severe/unstable angina, New York Heart Association (NYHA) grade III or IV symptomatic congestive heart failure.
• • 7. Gastrointestinal bleeding of clinical significance.
• • 8. Known presence of human immunodeficiency virus (HIV) or acquired routine immunodeficiency syndrome (AIDS) -associated disease, or active hepatitis B or C.
• • 9. There are psychiatric disorders that may increase the risk associated with participating in the study or taking the study drugs, or may interfere with the interpretation of the study results.
• 2. Any of the following treatments were received within a specific time frame before the study drug was taken:
• • 1. Major surgery in the previous 4 weeks. (Major surgery refers to laparotomy, thoracotomy, and laparoscopic resection of internal organs. On-off of abdomen was excluded)
• • 2. Radiotherapy with extended field within the previous 4 weeks or radiotherapy with limited field within the previous 2 weeks.
• • 3. Any investigational drugs within the previous 4 weeks.
• • 3. Presence of neurotoxicity of CTCAE grade 2 or above caused by adjuvant therapy.
• • 4. Pregnant or lactating women.
• • 5. The researcher did not consider it appropriate to enter the study.