Actively Recruiting
TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
Led by Henan Cancer Hospital · Updated on 2024-03-05
224
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, controlled, open-label, multicentre clinical study. This study is designed to evaluate the efficacy and safety of TAS-102 combined with bevacizumab as second-line maintenance therapy versus standard chemotherapy combined with bevacizumab as second-line continuous therapy in advanced colorectal cancer after second-line induction therapy.
CONDITIONS
Official Title
TAS-102 Combined With Bevacizumab for Second-line Maintenance Treatment of Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of unresectable colorectal adenocarcinoma confirmed by histopathology or cytology
- Completed 12 weeks of standard chemotherapy (FOLFOX, FOLFIRI, or CAPEOX) combined with bevacizumab as second-line induction therapy
- Achieved complete response, partial response, or stable disease per RECIST 1.1 criteria after second-line induction therapy
- No more than 6 weeks between last second-line induction therapy and randomization
- At least one measurable lesion by RECIST 1.1 criteria
- ECOG Performance Status between 0 and 2
- Estimated life expectancy of at least 12 weeks
- Adequate major organ function without need for blood component medication or cell growth factor correction therapy within 14 days prior to randomization
- Women of child-bearing potential must agree to use effective contraception or abstain from sex from informed consent until 90 days after last study drug dose; must have negative pregnancy test and not be lactating
- Male participants with partners of child-bearing potential must agree to use contraception or abstain from sex from consent until 90 days after last study drug dose; must agree not to donate sperm during this period
You will not qualify if you...
- Ongoing toxicity of grade 1 or higher from prior treatment, except alopecia, skin pigmentation, or chemotherapy-induced neurotoxicity
- History or evidence of interstitial lung disease or active noninfectious pneumonia
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg) with past hypertensive crisis or encephalopathy
- Bleeding tendency or high risk of bleeding
- Known bleeding disorders or recent use of full-dose anticoagulants or thrombolytics for therapy (low-dose aspirin or low-molecular-weight heparin allowed)
- Thrombotic or embolic events within 6 months prior to study treatment
- Severe, unhealed wounds, active ulcers, or untreated fractures
- Major surgery within 4 weeks before study or planned during study
- Inability to swallow tablets or conditions impairing gastrointestinal absorption
- Congenital or acquired immune deficiency such as HIV infection
- Active hepatitis B or C infection above specified thresholds
- Known brain or leptomeningeal metastases
- Active infection or fever over 38.5°C within 2 weeks before first dose, except tumor-related fever
- Acute or subacute intestinal obstruction or chronic inflammatory bowel disease
- Poorly controlled cardiac symptoms or disease
- Other malignancies within 5 years except certain skin or cervical cancers
- Pregnancy or lactation
- Genotype MSI-H
- Prior treatment with TAS-102
- Abdominal fistula, gastrointestinal perforation, or abscess within 6 months before treatment
- Investigator judgment deeming participation inappropriate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
Y
Ying Liu, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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