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AzTrials

Metastatic Colorectal CancerPhase 2NCT06485713

Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC

A Phase 2 study testing trifluridine/tipiracil combined with fufuquitinib, fufuquitinib and Trifluridine/tipiracil in people with Metastatic Colorectal Cancer and Drug Therapy, run by First Affiliated Hospital of Wenzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer, Drug Therapy
What is being tested?
trifluridine/tipiracil combined with fufuquitinib, fufuquitinib and Trifluridine/tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
1 Mar 2024to 1 Jun 2026
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time > 3 months.
  • 2.Patients with advanced colorectal adenocarcinoma confirmed by histopathology who had failed standard first - and second-line treatment.
  • 3.At least 1 measurable lesion was present according to RECIST1.1 criteria. 4.Good organ function, laboratory tests meet the following criteria:
  • Hemoglobin ≥90g/L;Absolute count of neutrophils (ANC) ≥1.5×109/L;Platelet ≥100×109/L;
  • ALT and AST≤2.5 upper limit of normal (ULN).ALP≤2.5 ULN;(if liver metastases ≤5 ULN);
  • Total bilirubin (TBIL) < 1.5 ULN;
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  • Serum creatinine (CR) <1.5 ULN or creatinine clearance (CCR) ≥50ml/min;
  • Serum albumin ≥30g/L;
  • International Normalized ratio (INR), prothrombin time (PT), activated partial thrombin time (APTT) ≤1.5ULN;
  • Thyrotropin (TSH) ≤ULN;If abnormal, T3 and T4 levels should be investigated, and normal levels can be included.
  • 5.cardiac color ultrasound: Left ventricular ejection fraction (LVEF) ≥50%. 6.Hypertension was well controlled. 7.Female participants of reproductive age should agree to use contraception during the study period and for 6 months after the study ends; Serum pregnancy test was negative within 7 days prior to study enrollment,and should be Non-lactation stage. Male subjects should agree to use contraception during the study period and for 6 months after the study ends.

Who cannot join

  • 1.Combined disease or history
  • .Present or present with other malignancies within 3 years.
  • .Have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, or intestinal obstruction)
  • .Gastrointestinal bleeding or perforation occurred during the first 4 weeks of enrollment
  • .Patients with ulcerative colitis, Crohn's disease, and active inflammatory bowel disease during the first 4 weeks of enrollment
  • .Uncontrolled pleural effusion, ascites, and moderate or greater pericardial effusion
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  • .Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.
  • .Received major surgical treatment or significant traumatic injury within 28 days prior to enrollment
  • .Patients with hematemesis, hematochezia, or any bleeding event ≥ CTCS AE level 3 within the previous 3 months, or with any signs of bleeding or history determined by the investigator to be ineligible for enrollment
  • .Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident, pulmonary embolism, etc
  • .A history of psychotropic substance abuse and inability to abstain
  • .Subjects with any severe and/or uncontrolled disease, including
  • Uncontrolled hypertension
  • Unstable angina pectoris / ≥ grade 2 cardiogenic chest pain;Myocardial infarction occurred within 12 months before randomization;≥ grade 2 heart failure;Restrictive heart disease;≥ grade 2 atrioventricular block, arrhythmia that cannot be stably controlled with drugs.
  • Active infection
  • Decompensated cirrhosis, active hepatitis;
  • Renal failure requires hemodialysis or peritoneal dialysis
  • A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
  • h.Diabetes with poorly controlled i.Urine routine showed urine protein ≥++, and 24h albuminuria quantitative > 1.0 g g.History of neurological or psychiatric disorders 2.Subjects who, in the investigator's judgment, have a concomitant medical condition that seriously endangers subjects' safety or interferes with the completion of the study, or are deemed unsuitable for enrollment for other reasons.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    pan yifei, 13506641535, 13506641535@139.com

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib Versus Trifluridine/Tipiracil and Fufuquitinib for Third-line Treatment of Unresectable Metastatic Colorectal Cancer

To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.

Being tested
trifluridine/tipiracil combined with fufuquitinib, fufuquitinib, Trifluridine/tipiracil
Keywords
Metastatic Colorectal Cancer, Fufuquitinib, trifluridine/tipiracil, Combination therapy
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/tipiracil combined with fufuquitinibDrug

    trifluridine/tipiracil combined with fufuquitinib

  • fufuquitinibDrug

    fufuquitinib

  • Trifluridine/tipiracilDrug

    Trifluridine/tipiracil

Study groups in NCT06485713
Study groupRoleWhat they receive
Experimental groupExperimentaltrifluridine/tipiracil combined with fufuquitinib
Receives: Drug: trifluridine/tipiracil combined with fufuquitinib
Control Group 1Active comparatorFufuquitinib
Receives: Drug: fufuquitinib
Control Group 2Active comparatorTrifluridine/tipiracil
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

    Measured: up to 24 weeks

Secondary outcomes (1)

  1. Total survival time

    Measured: up to 2 years

Timeline

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

  1. First posted3 Jul 2024
  2. Study start1 Mar 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06485713
Sponsor's protocol ID
KY2023-046
Status last verified
Jul 2024
First submitted
11 Apr 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PubMed 30207593

  • Quasar Collaborative Group; Gray R, Barnwell J, McConkey C, Hills RK, Williams NS, Kerr DJ. Adjuvant chemotherapy versus observation in patients with colorectal cancer: a randomised study. Lancet. 2007 Dec 15;370(9604):2020-9. doi: 10.1016/S0140-6736(07)61866-2.

    PubMed 18083404

  • Twelves C, Wong A, Nowacki MP, Abt M, Burris H 3rd, Carrato A, Cassidy J, Cervantes A, Fagerberg J, Georgoulias V, Husseini F, Jodrell D, Koralewski P, Kroning H, Maroun J, Marschner N, McKendrick J, Pawlicki M, Rosso R, Schuller J, Seitz JF, Stabuc B, Tujakowski J, Van Hazel G, Zaluski J, Scheithauer W. Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med. 2005 Jun 30;352(26):2696-704. doi: 10.1056/NEJMoa043116.

    PubMed 15987918

  • Yothers G, O'Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, Wolmark N. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol. 2011 Oct 1;29(28):3768-74. doi: 10.1200/JCO.2011.36.4539. Epub 2011 Aug 22.

    PubMed 21859995

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing trifluridine/tipiracil combined with fufuquitinib, fufuquitinib and Trifluridine/tipiracil in people with Metastatic Colorectal Cancer and Drug Therapy, run by First Affiliated Hospital of Wenzhou Medical 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 19 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: status not confirmed, as of the sponsor's last update on 3 Jul 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: up to 24 weeks). 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 NCT06485713, which also lists 4 linked publications.

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 3 Jul 2024.

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