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

NCT06485713 | Recruiting Phase 2 DMC

• 1 other identifier: KY2023-046
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Colorectal Cancer; Drug Therapy

Keywords

Metastatic Colorectal Cancer; Fufuquitinib; trifluridine/tipiracil; Combination therapy

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  up to 24 weeks

Secondary Outcomes (1)

• Total survival time

  up to 2 years

Study Arms (3)

Experimental group

EXPERIMENTAL

trifluridine/tipiracil combined with fufuquitinib

Drug: trifluridine/tipiracil combined with fufuquitinib

Control Group 1

ACTIVE COMPARATOR

Fufuquitinib

Drug: fufuquitinib

Control Group 2

ACTIVE COMPARATOR

Trifluridine/tipiracil

Drug: Trifluridine/tipiracil

Interventions

trifluridine/tipiracil combined with fufuquitinib DRUG

trifluridine/tipiracil combined with fufuquitinib

Experimental group

fufuquitinib DRUG

fufuquitinib

Control Group 1

Trifluridine/tipiracil DRUG

Trifluridine/tipiracil

Control Group 2

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 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time \> 3 months.
• Patients with advanced colorectal adenocarcinoma confirmed by histopathology who had failed standard first - and second-line treatment.
• 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;
• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 30207593 BACKGROUND

• 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.

  PMID: 18083404 BACKGROUND

• 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.

  PMID: 15987918 BACKGROUND

• 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.

  PMID: 21859995 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Trifluridine; trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: July 3, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)