Status:
RECRUITING
Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC
Lead Sponsor:
Fudan University
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 a...
Detailed Description
Based on the current diagnostic and treatment guidelines, regorafenib and TAS-102 monotherapy are both standard third-line treatment options for patients with metastatic colorectal cancer (mCRC), yet ...
Eligibility Criteria
Inclusion
- A total of 101 patients with metastatic colorectal cancer who meet the inclusion criteria and do not meet the exclusion criteria for receiving third-line or later-line therapy will be randomly assigned to receive corresponding treatment in a 1:1 ratio.
- 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.
Exclusion
- Patients who meet any of the following criteria will be excluded from the study:
- Proteinuria ≥2+ on dipstick or 24-hour urinary protein ≥1.0 g/24 h.
- Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), bleeding tendency, or receiving thrombolysis or anticoagulation therapy.
- Patients at risk of gastrointestinal bleeding, including those with active digestive ulcers and fecal occult blood (++) and those with histories of black stools or hematemesis within three months.
- Receiving systemic antitumor therapy, including chemotherapy, signal transduction inhibitors, or immune therapies, within three weeks prior to screening.
- Patients with uncontrolled hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg) despite antihypertensive medication, grade I or higher coronary heart disease, grade I or higher arrhythmia (including QTc interval prolongation with ≥450 ms for men and ≥470 ms for women), or grade I or higher heart failure.
- Patients with a history of thrombotic or embolic events requiring treatment within the preceding six months.
- Patients who have received radiation therapy targeting the selected target lesion.
- Symptomatic brain or meningeal metastasis.
- Uncontrolled pleural or peritoneal effusion.
- Receiving kidney dialysis.
- Serious or uncontrolled infection.
- Pregnant or lactating women or women of childbearing potential without adequate contraception.
- Multiple factors affecting oral drug administration (dysphagia, chronic diarrhea, and bowel obstruction).
- Patients who have been treated with small molecule tyrosine kinase inhibitors containing VEGFR (such as apatinib, fruquintinib, anlotinib, and lenvatinib).
- Patients who have been treated with TAS-102.
- Participation in another clinical study within four weeks prior to screening.
- Patients with comorbidities that could seriously endanger patients' safety or affect their completion of the study.
Key Trial Info
Start Date :
July 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 4 2026
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05970705
Start Date
July 1 2023
End Date
July 4 2026
Last Update
August 1 2023
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032