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Advanced Colorectal CancerPhase 2NCT05364489

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

A Phase 2 study testing Bevacizumab combined with Oxaliplatin and TAS-102 in people with Advanced Colorectal Cancer, run by The First Affiliated Hospital of Zhengzhou University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Colorectal Cancer
What is being tested?
Bevacizumab combined with Oxaliplatin and TAS-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
15 Jun 2022to 15 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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%)
Show all 24Show fewer
  • 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.
  • Dropout/Rejection Criteria:
  • The efficacy and/or safety evaluation cannot be performed due to the medication not prescribed in this protocol;
  • Participating in other anti-tumor treatments while participating in this study will be assessed by the investigator as affecting the efficacy evaluation.
  • Termination criteria:
  • The subject withdraws informed consent and requests to withdraw;
  • During the course of the study, the subject has a pregnancy event;
  • Subjects who cannot tolerate toxicity;
  • Disease progression;
  • Other circumstances in which the investigator considers it necessary to withdraw from the study.

About this study

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.

Read the detailed description

Eligible subjects received Bevacizumab in combination with Oxaliplatin and the TAS-102 investigational drug, and Bevacizumab and Oxaliplatin were administered intravenously on day 1 of each cycle. Medicine, every 14 days as a course of treatment, TAS-102 orally administered, 35mg/m2 (maximum single dose 80mg), bid, orally on the 1st to 5th days, 2 weeks as a course of treatment.

Patients were treated until objective disease progression, worsening symptoms, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. Clinicians will comprehensively evaluate according to clinical treatment guidelines and clinical practice treatment principles. For patients who still benefit after progression, the investigator can decide whether to continue the treatment with Bevacizumab combined with Oxaliplatin and TAS-102. Efficacy objectives were assessed after all subjects completed treatment/termination visits. Subjects were assessed for safety throughout the study period through laboratory tests and adverse event reporting.

Being tested
Bevacizumab combined with Oxaliplatin and TAS-102
Keywords
CRC, Bevacizumab, Oxaliplatin, TAS-102, first-line treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab combined with Oxaliplatin and TAS-102Drug

    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 .

Study groups in NCT05364489
Study groupRoleWhat they receive
Bevacizumab combined with Oxaliplatin and TAS-102ExperimentalEfficacy, safety and exploratory clinical study of Bevacizumab combined with Oxaliplatin and TAS-102 in first-line treatment of advanced colorectal cancer
Receives: Drug: Bevacizumab combined with Oxaliplatin and TAS-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months

Secondary outcomes (4)

  1. Disease Control Rate (DCR)

    Defined as the number of subjects whose tumors shrank or remained stable for a certain period of time, including complete remission (CR) and partial remission (PR), during the period from the time the subject received the treatment regimen of this study to the progression of the subject's disease in the analysis data set The percentage of the total population (unit: %).

    Evaluation method: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). Subjects must have measurable tumor lesions at baseline. The efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Subjects assessed as CR, PR, and SD were confirmed after 3 weeks (at the next protocol-specified efficacy assessment).

    Measured: Up to 24 months

  2. Objective response rate (ORR)

    It is defined as the number of subjects with the best response effect as complete remission (CR) or partial remission (PR) during the period from the start of the subjects receiving the treatment regimen of this study to the progression of the subjects' disease in the total number of subjects in the analysis data set. percentage of the population（%）.

    Measured: Up to 24 months

  3. Overall survival (OS)

    Defined as the time from randomization to death from any cause（Unit: month）.

    Measured: Up to 24 months

  4. Drug-Related Safety Indicators

    Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events（n，%）。

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start15 Jun 2022 (estimated)
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05364489
Sponsor's protocol ID
BOT-CRC-1LT
Status last verified
May 2022
First submitted
27 Apr 2022
Last updated
20 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab combined with Oxaliplatin and TAS-102 in people with Advanced Colorectal Cancer, run by The First Affiliated Hospital of Zhengzhou University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05364489.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.

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