A Randomized, Controlled, Multicenter Phase II Trial of Regorafenib Combined With Trifluridine/Tipiracil Versus Regorafenib Monotherapy in Patients With Metastatic Colorectal Cancer Who Failed at Least Two Lines of Systematic Therapy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ The subjects must meet all of the following criteria to be eligible for this study:

• Patients with histologically confirmed recurrent/metastatic colorectal adenocarcinoma.

• Patients who have failed at least one prior standard first- or second-line therapy, including fluoropyrimidine-based therapy, oxaliplatin, irinotecan, and bevacizumab. Treatment failure is defined as either radiographic evidence of disease progression or unacceptable toxicity during treatment or within three months following completion of therapy.

• (Note: a. each line of therapy should include at least one or more chemotherapy agents administered for at least one cycle; b. adjuvant/neoadjuvant therapy is allowed. If relapse or metastasis occurs during or within six months after completion of adjuvant/neoadjuvant therapy, it is considered a failure of first-line chemotherapy for progressive disease. c. For patients with RAS/RAF wild-type tumors, the use of an EGFR inhibitor is not required.)

• At least one measurable lesion, with the longest diameter ≥10 mm on spiral CT or ≥20 mm on conventional CT (RECIST 1.1 criteria).

• ECOG performance status of 0-2.

• Life expectancy of ≥12 weeks.

• Adequate bone marrow, hepatic, and renal function measured within the screening period prior to randomization: absolute neutrophil count (ANC) ≥1.5 × 109 /L, hemoglobin ≥ 8.0 g/dL, platelet count ≥ 75 × 109 /L, total bilirubin \<1.5 × ULN, ALT and AST \<2.5 × ULN (≤5 × ULN for patients with liver involvement), serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min.

• Women of childbearing potential must use effective contraception.

• Voluntarily participating in this study, signing the informed consent form, understanding the purpose of the study and the necessary procedures, and willing to participate in this study.

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-07-04
Participants
Target number of participants: 101
Treatments
Experimental: A: Regorafenib+TAS-102 combination therapy
Regorafenib 80mg ,orally, once a day, d1-28, every 28 days, TAS-102,35mg/m2, orally,twice a day, d1-5 \& d15-19,every 28 days
Active_comparator: B:Regorafenib monotherapy
Regorafenib, 120mg orally, once a day, d1-21, every 28 days (If the patient's body surface area is less than 1.5m2, the starting dose of regorafenib is 80mg)
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov