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Metastatic Colorectal CancerPhase 2NCT04247984

A Comparison of mXELIRI Regimen and FOLFIRI Combined Bevacizumab Regimen as First-line Chemotherapy Regimen for Metastatic Colorectal Cancer

A Phase 2 study testing Bevacizumab, Capecitabine and Irinotecan in people with Metastatic Colorectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase II, multicenter，randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Bevacizumab, Capecitabine and Irinotecan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteChina
Study dates
1 May 2018to 31 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent;
  • ECOG≤1;
  • Age≥18；
  • Histologically or cytologically confirmed unresectable metastatic colorectal cancer with no previous chemotherapy or molecular targeted therapy;
  • At least one evaluable lesion per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1;
  • life expectancy >12 weeks;
  • Adequate bone marrow and organ function. Hb≥9 G/L; Absolute neutrophil ≥ 1.5 G/L; PLT ≥100 G/L ;ALT/AST ≤2 ULN or ≤5ULN with liver metastases;ALP ≤2.5 ULN or ≤5ULN with liver metastases or ≤10ULN with bone metastases ; TBIL ≤1.5 ULN; Cr≤1.0 ULN;
  • Urinary protein excretion < 2+ (dipstick). If > or equal 2+ proteinuria is detected with dipstick, a 24-hour period urine test will be performed and the result should be < or equal to 1 g/24 hours to permit the inclusion of the patient in the clinical trial.

Who cannot join

  • Pregnant or lactating women；
  • Sexually active women (of childbearing potential) or men unwilling to adopt an effective method of birth control during the course of the study；
  • Previous treatment with Irinotecan or anti-VEGF antibodies;
  • Any previous malignancy within 5 years prior to study entry, except for cured basal cell carcinoma of skin or carcinoma-in-situ of the uterine cervix;
  • History of acute coronary syndromes (including myocardial infarction and unstable angina) within 6 months prior to study entry, or history or evidence of current ≥ Class II congestive heart failure as defined by New York Heart Association (NYHA);
  • Uncontrolled hypertension and severe arrhythmia requiring drug treatment;
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  • Present with non-healing fractures or wounds of skin;
  • History of previous abdominal fistula, gastrointestinal perforation or intra-abdominal abscesses within 6 months before randomization;
  • Major surgery, open surgical biopsy or significant traumatic injury within 4 weeks or needle biopsy within 7 days before randomization before randomization；
  • Evidence or history of bleeding diathesis or coagulopathy；
  • Known or suspected allergy or hypersensitivity to any component of Bevacizumab, xeloda, irinotecan, or 5-FU/LV;
  • Clinical or radiological evidence of CNS metastases;
  • History of unexpected serious adverse events to fluoropyrimidine treatments or known dihidropyrimidine dehydrogenase (DPD) deficiency;
  • Patients subjected to organ allografts who require immunosuppressive treatment;
  • Prior adjuvant or neoadjuvant treatment for metastatic colorectal cancer is allowed, as long as it has concluded at least 6 months before beginning the treatment of the study;
  • If adjuvant treatment has previously been administered, the patients cannot have shown progression of the disease during treatment nor during the 6 months following termination thereof;
  • Prior radiotherapy is allowed if it has not been administered in the target lesions selected for this study, unless progression of said lesions in the irradiated field is documented, and as long as treatment has concluded at least 4 weeks before beginning the study;
  • Prior surgical treatment of the disease in stage IV is allowed;
  • Use of full dose of oral or parenteral anticoagulants ( at least 10 days before the initial study treatment or thrombolytic agents. Low dose of warfarin is allowed, with an INR ≤ 1.5;
  • Subject requiring chronic use of high dose aspirin (> 325 m/day) or non-steroidal anti-inflammatory treatment ;
  • Received any investigational drug or agent/ procedure, i.e. participation in another treatment trial within 4 weeks of randomisation.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital & Institute, Chinese Academy of Medical Sciences

    Beijing, 100021

Other trials in China

About this study

Official title: An Efficacy and Safety Study of mXELIRI Versus. FOLFIRI + Bevacizumab Therapy as First-line Chemotherapy in Metastatic Colorectal Cancer

This is a Phase II, multicenter，randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI as first-line treatment in patients with metastatic colorectal cancer (mCRC).

Read the detailed description

This is a Phase II, multicenter，randomized, two arms, open-labeled, controlled clinical trial. This trial was conducted to evaluate the efficacy and safety of bevacizumab (Avastin®) plus mXELIRI compared with bevacizumab (Avastin®) plus FOLFIRI in not previously treated patients with metastatic colorectal cancer (mCRC). In experimental group, untreated patients with metastatic colorectal cancer will receive Irinotecan 150 mg/m2 (D1, q2w) , Xeloda 2000mg/m2 (D1-10, q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment. While in control group, patients with metastatic colorectal cancer will receive Irinotecan 180 mg/m2 (D1, q2w) , CF 300mg/m2 (D1 q2w), 5FU 400mg/m2, D1 2400 mg/m2, civgtt 44h (q2w) and bevacizumab 5mg/kg (D1, q2w) for 6-9 cycles as the first-line treatment.The primary endpoint is progression-free survival. Overall survival, Objective Response rate, adverse event and life quality will be assessed as secondary outcomes.

Keywords
XELIRI, FOLFIRI
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • BevacizumabBiological

    Also called Avastin

    5 mg/kg intravenously administered on day 1 of a 2-week cycle.

  • CapecitabineDrug

    Also called Xeloda

    2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.

  • IrinotecanDrug

    Also called CPT-11

    180 mg/m2 intravenously administered on day 1 of a 2-week cycle.

  • 5-FUDrug

    Also called Fluorouracil

    400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.

  • CFDrug

    300 mg/m2 intravenously administered on day 1 of a 2-week cycle.

  • IrinotecanDrug

    Also called CPT-11

    150 mg/m2 intravenously administered on day 1 of a 2-week cycle.

Study groups in NCT04247984
Study groupRoleWhat they receive
mXELIRI+ BevacizumabExperimentalNot described
Receives: Biological: Bevacizumab; Drug: Capecitabine; Drug: Irinotecan
FOLFIRI + BevacizumabActive comparatorNot described
Receives: Biological: Bevacizumab; Drug: Irinotecan; Drug: 5-FU; Drug: CF

What is being measured

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

  1. Progression-free survival (PFS)

    Time from the date of enrollment to the earlier of the date of confirmed progression or death from any cause.

    Measured: 6 Months

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    Proportion of eligible patients with measurable lesions with a best overall response of CR or PR assessed by the attending physician.

    Measured: 6 Months

  2. Overall survival (OS)

    Time from the date of enrollment to death from any cause.

    Measured: 1 Year

  3. Incidence of Adverse Events

    The incidence of adverse events as graded by NCI-CTCAE v 4.0.

    Measured: 6 Months

  4. Quality of life (QoL) Questionnaire

    Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score

    Measured: 6 Months

Timeline

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

  1. First posted30 Jan 2020
  2. Study start1 May 2018
  3. Primary completion1 Apr 2021
  4. Study completion31 Jan 2022

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04247984
Sponsor's protocol ID
NCC-000583
Status last verified
Mar 2022
First submitted
23 Jan 2020
Last updated
11 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Capecitabine and Irinotecan in people with Metastatic Colorectal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.

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 8 inclusion and 21 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: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 6 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 NCT04247984.

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 11 Mar 2022.

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