Efficacy, Safety and Exploratory Clinical Study of Bevacizumab Combined With Oxaliplatin and TAS-102 in First-line Treatment of Advanced Colorectal Cancer

NCT05364489 | Not Yet Recruiting Phase 2

• 1 other identifier: BOT-CRC-1LT
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-arm, prospective, open-label observational clinical study to evaluate the efficacy and safety of Bevacizumab combined with Oxaliplatin and TAS-102 in patients with advanced unresectable rectal cancer.

Conditions

Advanced Colorectal Cancer

Keywords

CRC; Bevacizumab; Oxaliplatin; TAS-102; first-line treatment

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Defined as the time from randomization to tumor progression in any aspect or death from any cause（Unit: month）. Assessed according to RECIST 1.1 criteria, analysis of this indicator included tumor evaluation results during study treatment and follow-up. If the patient has several indicators that can be determined as PD, the first indicator is used for PFS analysis; recurrence, new lesions or death are considered to have reached the study endpoint 1. The patient uses other systemic or targeted observation targets. Lesional anti-tumor therapy is also considered tumor progression.

  Up to 24 months

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  Up to 24 months

• Objective response rate (ORR)

  Up to 24 months

• Overall survival (OS)

  Up to 24 months

• Drug-Related Safety Indicators

  Up to 36 months

Study Arms (1)

Bevacizumab combined with Oxaliplatin and TAS-102

EXPERIMENTAL

Efficacy, safety and exploratory clinical study of Bevacizumab combined with Oxaliplatin and TAS-102 in first-line treatment of advanced colorectal cancer

Drug: Bevacizumab combined with Oxaliplatin and TAS-102

Interventions

Bevacizumab combined with Oxaliplatin and TAS-102 DRUG

Bevacizumab (Anda, Qilu Pharmaceutical): 5 mg/kg, repeated every 2 weeks, administered by intravenous drip (ivgtt). Oxaliplatin: 85 mg/m2, repeated every 2 weeks, by intravenous infusion (ivgtt). TAS-102: 35 mg/m2 (maximum single dose 80 mg), orally, twice a day, on days 1 to 5, repeated every 2 weeks. Continuous administration until disease progression, death, toxicity intolerance, withdrawal of informed consent, or other reasons specified in the protocol; for patients who still benefit after comprehensive evaluation after initial disease progression, the investigator may decide whether to continue the treatment with the experimental drug .

Bevacizumab combined with Oxaliplatin and TAS-102

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age: ≥18 years and ≤75 years;
• ECOG score 0\~1 points;
• advanced colorectal cancer patients
• According to RECIST1.1 criteria, there is at least one measurable target lesion, and tumor imaging evaluation is performed within 28 days before the first dose;
• Expected survival time ≥ 12 weeks;
• Major organ function is normal, that is, the following criteria are met:
• （1）Routine blood examination standards must meet: ANC ≥1.5×109/L; PLT≥90×109/L; Hb ≥90g/L (no blood transfusion within 14 days); (2) Biochemical tests should meet the following criteria: ALB≥30g/L; (no ALB transfusion within 14 days); TBIL≤Upper limit of normal (ULN); ALT and AST≤2.5 times upper limit of normal (ULN), if liver metastasis , then ALT and AST≤5ULN; alkaline phosphatase≤2.5 times the upper limit of normal (ULN); BUN and Cr≤1.5×ULN and creatinine clearance rate≥50mL/min (CockcroftGault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF≥55%); (4) QT interval (QTcF) corrected by Fridericia method of 18-lead ECG in females \<470 ms; 7. For premenopausal or surgically sterilized female patients: Consent to abstinence or use of effective contraception during treatment and for at least 7 months after the last dose of study treatment; 8. Voluntarily joined the study and signed the informed consent.

You may not qualify if:

• Patients who have received first-line standard therapy;
• Previous antitumor therapy or radiation therapy for any malignant tumor;
• concurrently receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• Has undergone major surgical procedures not related to colorectal cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
• Serious heart disease or discomfort, including but not limited to the following:
• Diagnosed history of heart failure or systolic dysfunction (LVEF \< 50%)
• High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \>100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV blocklag)
• Angina pectoris requiring antianginal drug treatment
• Clinically significant heart valve disease
• ECG showing transmural myocardial infarction
• Poorly controlled hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg)
• Inability to swallow, bowel obstruction, or other factors that interfere with drug taking and absorption;
• Known history of allergies to the drug components of this regimen; history of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• Pregnant or lactating female patients, female patients of childbearing potential with a positive baseline pregnancy test, or patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug;
• Serious comorbidities or other comorbidities that would interfere with planned treatment, or any other condition in which the patient is considered unsuitable for participation in this study by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

MeSH Terms

Interventions

Oxaliplatin; trifluridine tipiracil drug combination

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician，Department of Oncology, The First Affiliated Hospital of Zhengzhou University

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 6, 2022
• Study Start: June 15, 2022
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share