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Status:

RECRUITING

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

Lead Sponsor:

First Affiliated Hospital of Wenzhou Medical University

Conditions:

Metastatic Colorectal Cancer

Drug Therapy

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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
  • 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.

Key Trial Info

Start Date :

March 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT06485713

Start Date

March 1 2024

End Date

June 1 2026

Last Update

July 3 2024

Active Locations (1)

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1

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China