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Metastatic Colorectal CancerPhase 2BEV-TASIRINCT06242067

Second-line Treatment of Metastatic Colorectal Cancer

A Phase 2 study testing Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Qilu Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Trifluridine/tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
23 Apr 2023to Dec 2026
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

  • All subjects are required to sign an informed consent form before starting the study-related procedure
  • Age 18-75 years old, male or female.
  • have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, life expectancy >3 months.
  • Histologically or cytological proven metastatic or recurrent adenocarcinoma of the colon or rectum.
  • Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and oxaliplatin with bevacizumab or cetuximab targeted therapy as the first-line regimen.
  • Recurrence or metastasis within 12 months after completion of adjuvant/neoadjuvant therapy with oxaliplatin and fluoropyrimidine-based drugs is also considered as the failure of first-line chemotherapy.
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  • At least one measurable metastatic lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
  • Adequate organ function: bone marrow, kidney, liver function (within 7 days before treatment start) Absolute neutrophil count ≥ 1.5×109/L Platelet count ≥ 100×109/L Hemoglobin≥ 90g/L (no history of blood transfusion within 7 days); Creatinine clearance≥ 60 ml/min (Cockcroft-Gault formula) Bilirubin ≤ 1.5 x the upper limit of normal (ULN) Glutamate aminotransferase (AST)/ alanine aminotransferase (ALT) levels ≤2.5 x ULN or =< 5 x ULN if with hepatic metastases; Alkaline phosphatase (AKP) ≤ 2.5 x ULN or =< 5 x ULN if with hepatic metastases;
  • Urine protein <1+ or 24-hour urine protein <1 gram;
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN or within the range if receiving anticoagulant therapy;
  • Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence; IUDs, etc) during the study period and within 90 days of the last study medication. All female patients will be considered fertile unless they have spontaneous menopause, artificial menopause, or sterilization (e.g., hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).

Who cannot join

  • First-line treatment with irinotecan;
  • Patients with KRAS/NRAS/BRAF wild-type and not treated with cetuximab in the first line.
  • Patients with dMMR/MSI-H (deficient mismatch repair/microsatellite instability-high) status;
  • Symptomatic brain or meningeal metastases (except for brain metastases that have undergone local radiotherapy or surgery for more than 6 months and stable disease control)
  • Previous or current severe bleeding (bleeding >30ml within 3 months), coughing up blood (>5ml of fresh blood within 4 weeks) or cerebrovascular accident (excluding lacunar cerebral infarction, minor cerebral ischemia or transient ischemic attack, etc.) within half a year before the first use of the study drug, myocardial infarction, unstable angina, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and 470 ms for women≥) (QTc interval is calculated by Fridericia formula). According to the New York College of Cardiology (NYHA) standard class III or IV cardiac insufficiency or cardiac ultrasound: left ventricular ejection fraction (LVEF) < 50%.
  • Uncontrolled hypertension: systolic blood pressure >140mmHg, diastolic blood pressure > >90mmHg;
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  • Digestive tract diseases or states that the investigator determines may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases or active bleeding in unresected gastrointestinal tumors, or other conditions that the investigator determines may cause gastrointestinal bleeding or perforation or obstruction;
  • History of second primary malignancy within 5 years prior to enrollment, excluding basal cell skin carcinoma or in-situ cervical carcinoma after radical resection;
  • Have known active infection, including but not limited to human immunodeficiency virus (HIV) infection, a history of liver disease known to be significant, including but not limited to hepatitis B virus (HBV) infection and HBV DNA positive (≥1×104/ml); hepatitis C virus infection (HCV) with positive HCV RNA (≥1×103/ml), or cirrhosis, etc.
  • Unresolved toxicities from prior therapy of > grade 1, excluding alopecia; Any other disorders, metabolic abnormality, physical examination abnormality, or laboratory abnormality which has reason to suspect that the patient not suitable for the study or will affect the interpretation of the results. Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

xiangling Wang, Dr. contact

8653182169841

xlwang71@163.com

China1 site, 1 recruiting

  • Qilu hospital of Shandong University

    Jinan, Shandong, 250012

    xiangling Wang, Dr., 8653182169841, xlwang71@163.com

    Jing Hao

    Recruiting

Other trials in China

About this study

Official title: Irinotecan in Combination With Trifluridine-tipiracil and Bevacizumab in Pre-treated Metastatic Colorectal Cancer

The goal of this multicenter, single-arm, observational cohort study is to investigate the efficacy and safety of irinotecan in combination with trifluridine-tipiracil and bevacizumab in colorectal cancer with prior oxaliplatin and fluoropyrimidine-based chemotherapy (including 5-FU/capecitabine/S-1) exposure in the metastatic setting or within 12 months of recurrence.

Being tested
Trifluridine/tipiracil
Keywords
colorectal cancer, bevacizumab, trifluridine-tipiracil/TAS-102, irinotecan
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Trifluridine/tipiracilDrug

    Also called Irinotecan, Bevacizumab

    patients received biweekly Trifluridine/tipiracil (30 mg/m2 twice daily; days 1-5), irinotecan (150 mg/m2; day 1) and bevacizumab (5 mg/kg; day 1).

Study groups in NCT06242067
Study groupRoleWhat they receive
Irinotecan,Trifluridine-tipiracil in combination with BevacizumabExperimentalNot described
Receives: Drug: Trifluridine/tipiracil

What is being measured

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

  1. progression-free survival(PFS)

    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,

    Measured: from the date of randomization up to 36 months

Secondary outcomes (5)

  1. objective response rate(ORR)

    ORR was defined as the percentage of participants who had shown complete response (CR) or partial response (PR) as the best overall response in accordance with the RECIST 1.1 criteria after randomization.

    Measured: from the date of randomization up to 36 months

  2. disease control rate(DCR)

    Defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).

    Measured: from the date of randomization up to 36 months

  3. overall survival(OS)

    OS was defined as the time from the day of randomization (Day 0) until death by all causes.

    Measured: from the date of randomization up to 36 months

  4. Adverse Events(safety)

    Adverse events were recorded according to Common Terminology Criteria for Adverse Events (version 5.0) of the National Cancer Institute that participants received at least one dose of protocol treatment after randomization.

    Measured: Up to 28 days after discontinuation of study drug or start of subsequent therapy.

  5. Duration of Response (DOR)

    From the date of response until the date of first documented disease progression or death.

    Measured: from the date of randomization 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 posted5 Feb 2024
  2. Study start23 Apr 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06242067
Sponsor's protocol ID
KYLL-202210-057-1
Acronym
BEV-TASIRI
Status last verified
Apr 2023
First submitted
28 Jan 2024
Last updated
5 Feb 2024
Results posted
No
Data monitoring committee
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 Trifluridine/tipiracil in people with Metastatic Colorectal Cancer, run by Qilu Hospital of Shandong University 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 5 Feb 2024. 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?

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?

Contact xiangling Wang, Dr. (8653182169841, xlwang71@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival(PFS) (time frame: from the date of randomization up to 36 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 NCT06242067.

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 5 Feb 2024.

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