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 2026-06-01
20
Participants Needed
1
Research Sites
17 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
Researchers are studying whether a combination of two drugs, fruquintinib and tislelizumab, can help control colorectal cancer in patients who have completed treatment but still show signs of minimal residual disease (MRD) through positive ctDNA tests. This phase 2 trial focuses on patients with microsatellite stable colorectal adenocarcinoma who have finished curative treatments including chemotherapy. The study aims to measure how well the treatment clears ctDNA at 3 and 6 months, as well as to assess disease-free survival, overall survival, and safety. Participants will receive treatment with fruquintinib taken orally and tislelizumab given intravenously. The study does not include randomization or placebo groups; all participants receive the combination therapy. The treatment period and dosing schedules are designed to evaluate the effects on MRD as detected by the Signatera assay. The trial includes careful monitoring of organ function and blood counts to ensure participant safety. Throughout the study, participants will undergo regular ctDNA testing to monitor minimal residual disease status, along with assessments for disease progression and survival. Safety and adverse events will be tracked for about one year from the start of treatment. Participants must be able to provide informed consent and will be closely observed for treatment tolerability and effectiveness. The study will continue until April 2028, allowing long-term follow-up on outcomes and safety.
CONDITIONS
Brief 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...
- Participants must have histologically or cytologically confirmed microsatellite stable colorectal adenocarcinoma.
- Completed curative treatments for stage II, III, or IV colorectal cancer including at least 3 months of oxaliplatin-containing chemotherapy.
- No evidence of radiographic disease within 28 days before or after a positive ctDNA test.
- Positive ctDNA assay indicating minimal residual disease by Signatera MRD assay.
- Adequate organ and marrow function including specific blood count and liver function requirements.
- ECOG performance status of 0 or 1.
- Age 18 years or older.
- Women of child-bearing potential and men must agree to use adequate contraception before, during, and for 4 months after study treatment.
- Able to understand and willing to sign informed consent.
You will not qualify if you...
- Presence of other active invasive malignancies that may affect ctDNA analysis.
- Clinically significant electrolyte abnormalities.
- Severe autoimmune or cardiovascular disorders that interfere with study participation.
- Active or history of autoimmune diseases that may worsen.
- Persistent adverse events from previous treatments at grade 2 or higher except alopecia and neuropathy.
- Recent systemic anti-cancer therapies or investigational treatments within 4 weeks.
- Recent use of systemic targeted therapies within 5 half-lives or 4 weeks.
- QTcF interval of 480 ms or longer.
- Conditions that may affect investigational drug use or study result interpretation.
- Known allergies to the study drugs or excipients.
- Pregnancy or lactation.
- Inability to take oral medication or absorption issues.
- Concurrent investigational agents.
- Use of corticosteroids or immunosuppressive medications within 14 days except specific exceptions.
- Live vaccines within 28 days before first dose except inactivated seasonal influenza vaccine.
- Untreated or inadequately treated active hepatitis B or C, or HIV infection.
- Major surgery within 30 days before first drug administration.
- Prior allogeneic stem cell or organ transplantation.
- Certain cardiovascular risks including recent heart attack, heart failure, arrhythmias, stroke, uncontrolled hypertension, syncope or seizures.
- Recent use of strong CYP3A inducers within 2 weeks.
- Active gastrointestinal ulcers or disease with bleeding risk.
- Clinically significant bleeding history within 2 months.
- History of arterial thrombosis within 12 months before first dose of study drug(s).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 year
Participants receive treatment with Fruquintinib by mouth and Tislelizumab by intravenous infusion to target minimal residual disease in colorectal cancer.
Regular visits for treatment administration and safety monitoring
Duration - Up to study completion (around 1 year after treatment start)
Participants are monitored for safety and adverse events after completing treatment.
Visits scheduled as needed for safety assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Arvind Dasari, MD
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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