Actively Recruiting
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Led by M.D. Anderson Cancer Center · Updated on 2026-04-06
20
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
BeiGene
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find out if a combination of fruquintinib and tislelizumab can control CRC in patients who have received treatment for the disease but still have "positive" ctDNA tests for MRD (meaning there is evidence of MRD based on this test).
CONDITIONS
Official Title
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed microsatellite stable colorectal adenocarcinoma
- Completed curative treatment for stages II, III, or IV colorectal cancer including at least 3 months of oxaliplatin-containing chemotherapy
- No radiographic evidence of disease within 28 days before or after a positive ctDNA test
- Positive ctDNA assay indicating minimal residual disease
- Adequate organ and marrow function with specified blood counts and biochemical parameters
- ECOG performance status of 0 or 1
- Age 18 years or older
- Able to understand and willing to sign informed consent
- Willing to use effective contraception during the study and for 4 months after last dose
You will not qualify if you...
- Presence of other active invasive malignancies that could interfere with ctDNA analysis
- Significant electrolyte abnormalities judged clinically relevant
- Severe autoimmune or cardiovascular disorders that may interfere with participation
- Active or history of autoimmune diseases that may worsen or relapse
- Persistent adverse events from prior treatment grade 2 or higher except alopecia and neuropathy
- Use of systemic anti-cancer or investigational therapies within 4 weeks prior to study drug
- Use of systemic small molecule-targeted therapies within 5 half-lives or 4 weeks prior to study drug
- QTcF interval 480 ms or longer
- Conditions that prohibit investigational product use or increase risk of harm
- Known hypersensitivity to study drugs
- Pregnancy or lactation
- Unable to take oral medication or absorb study drug
- Receiving other investigational agents
- Need for systemic corticosteroids or immunosuppressive drugs within 14 days before study drug with specific exceptions
- Live vaccine within 28 days before study drug
- Untreated or inadequately treated hepatitis B, hepatitis C, or HIV infection
- Major surgery within 30 days before study drug
- Prior allogeneic stem cell or organ transplantation
- Recent major cardiovascular events or uncontrolled hypertension
- Syncope or seizure within 28 days before study drug
- Recent use of strong CYP3A inducers
- Active gastrointestinal ulcers or diseases with bleeding risk
- Clinically significant hemorrhage within 2 months before screening
- Arterial thrombus within the last 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Arvind Dasari, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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