Actively Recruiting
Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
Led by Fudan University · Updated on 2025-08-06
119
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
CONDITIONS
Official Title
Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with unresectable colorectal adenocarcinoma confirmed by tissue tests
- Failed first-line standard therapy and planned to receive second-line standard therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1
- Estimated life expectancy of 3 months or more
- Adequate function of major organs
- Voluntarily agree to participate and sign informed consent with good compliance
You will not qualify if you...
- Allergy to the study drug or its components
- Pregnant or breastfeeding women
- Previous treatment with TAS-102
- Ongoing grade 2 or higher toxicity from prior treatment (except alopecia, skin pigmentation, or chemotherapy-related nerve damage)
- Known bleeding disorders or recent use of full-dose anticoagulants (low-dose aspirin or low-molecular-weight heparin allowed)
- Other serious illnesses including:
- Other cancers in past 5 years except certain skin or cervical cancers
- Brain or leptomeningeal metastases
- Active infection or fever above 38.5°C
- Poorly controlled high blood pressure with history of hypertensive crisis or encephalopathy
- Bleeding disorders
- Recent serious blood clots within 6 months
- Severe or unhealed wounds, active ulcers, or untreated fractures
- Recent heart attack, unstable angina, or severe heart failure in past 12 months
- Intestinal blockage or chronic inflammatory bowel disease
- Serious psychological or psychiatric conditions affecting study participation
- Major surgery within 4 weeks before study start or planned during study
- Inability to swallow pills or gastrointestinal conditions affecting absorption
- Investigator assessment deeming participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wenhua Li, Ph.D
CONTACT
W
Wenhua Li, Ph.D
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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