Actively Recruiting
Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2024-04-02
70
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In mCRC, response to second-line chemotherapy is limited, and few treatment options are available. It is urgent to design an optimal second-line treatment regimen to improve the response rate and prolong the survival of patients with mCRC. Several studies preliminarily demonstrated that irinotecan, TAS-102 plus bevacizumab regimen could bring promising efficacy with a tolerable safety profile for patients with mCRC as a second-line treatment. This phase I/II study was aimed to determine the recommended phase II dose (RP2D) of the combination of TAS-102, irinotecan, and bevacizumab for future clinical trials in patients with mCRC refractory to both fluoropyrimidine and oxaliplatin and to evaluate its safety and preliminary efficacy.
CONDITIONS
Official Title
Irinotecan, TAS-102 Plus Bevacizumab as a Second-Line Therapy in mCRC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed colorectal adenocarcinoma
- Clinically diagnosed metastatic colorectal cancer based on CT or MRI
- Previously received oxaliplatin-based first-line chemotherapy with or without targeted therapy, immunotherapy, or radiotherapy
- Age between 18 and 70 years
- ECOG performance status score of 0 or 1 with no recent deterioration within 2 weeks before treatment
- Adequate organ function confirmed by laboratory tests including hemoglobin ≥90g/L, white blood cell count ≥3.5×10^9/L, absolute neutrophil count ≥1.5×10^9/L, platelet count ≥100×10^9/L, serum creatinine within normal limits or creatinine clearance ≥60ml/min, total serum bilirubin ≤1.5 times upper normal limit, and liver enzymes ≤2.5 times upper normal limit
- Signed informed consent
You will not qualify if you...
- Histological types other than adenocarcinoma (e.g., squamous carcinoma, neuroendocrine carcinoma)
- Known allergy to irinotecan, TAS-102, bevacizumab, or their components
- Previous irinotecan treatment with disease progression (except progression during maintenance therapy)
- Inability to swallow or malabsorption syndrome
- Recent recurrent bleeding or blood transfusion within 2 weeks
- Major surgery within the past 4 weeks (biopsy excluded)
- Previous or concurrent cancer diagnosed within 5 years, except certain curatively treated cancers
- Recent history (within 6 months) of abdominal fistula, gastrointestinal perforation, intestinal obstruction, chronic diarrhea, or inflammatory bowel disease
- Severe cardiac dysfunction including left ventricular ejection fraction <50%, congestive heart failure grade ≥2, unstable angina, recent stroke, or myocardial infarction within 6 months
- Uncontrolled hypertension or diabetes
- History of serious heart rhythm disorders
- Active infections including hepatitis B, hepatitis C, syphilis, HIV, or pulmonary tuberculosis
- Severe respiratory diseases or history of pneumonitis
- Active infections requiring treatment within 2 weeks
- History of drug or psychiatric abuse
- Pregnant or lactating women
- Patients unwilling to use contraception if of childbearing potential
- Any other significant disease or condition that may affect safety or study results
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Y
Yongkun Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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