Phase 2 Fruquintinib and Tislelizumab for Colorectal Cancer with Minimal Residual Disease
This study is testing if a combination of two drugs, fruquintinib and tislelizumab, can help clear up remaining cancer cells in people with colorectal cancer. These are patients who have already finished their initial cancer treatment, including at least three months of oxaliplatin-containing chemotherapy, but still show signs of "minimal residual disease" (MRD) through a blood test called ctDNA. The main goal is to see how many participants have their ctDNA clear up after six months of treatment. We are also looking at how safe the drugs are and how well people tolerate them. This study aims to enroll 20 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be monitored throughout the study, for an average of one year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07136077
A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~15 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:TislelizumabFruquintinib
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year.
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Arvind Dasari, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Has other concomitant active, invasive malignancies that may interfere with ctDNA analysis (known clonal hematopoesis of unknown potential allowed).
Has serum electrolytes, potassium, calcium, or magnesium levels outside of the normal laboratory reference range which are clinically significant in the investigator's judgment.
Has significant concomitant health conditions including but not limited to severe autoimmune or cardiovascular disorders that may interfere with participation in the study.
Active autoimmune diseases or history of autoimmune diseases that may worsen or relapse per treating providers' evaluation.
Has a persistent adverse event from previous treatment, except alopecia and neuropathy, greater than or equal to grade 2 of the Common Toxicity Criteria for Adverse Events (CTCAE) v. 5.0
Systemic anti-neoplastic therapies or any investigational therapy within 4 weeks prior to the first dose of study drug, including chemotherapy, radical radiotherapy, hormonotherapy, biotherapy, and immunotherapy.
Systemic small molecule-targeted therapies (eg, tyrosine kinase inhibitors) within 5 halflives or 4 weeks (whichever is shorter) prior to the first dose of study drug.
Mean QT interval corrected by the method of Fridericia (QTcF) ≥480 ms.
Has another disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other condition that investigators suspect may (a) prohibit use of the investigational product, (b) affect interpretation of study results, or (c) put the participant at undue risk of harm
Has known hypersensitivity to the trial drugs or their excipients or is at risk of allergic of anaphylactic reaction to drug product according to the Investigator's judgement.
Is pregnant or lactating.
Is unable to take medication orally or has any other condition that investigators believe may affect absorption of the investigational product.
Is receiving any other investigational agent.
Any condition that requires systemic treatment with either corticosteroid (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤14 days before the first dose of study drug(s), with the following exceptions:
Adrenal replacement (dose of ≤10 mg daily of prednisone or equivalent).
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
Short course (≤7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
Live vaccine ≤28 days before the first dose of study drug(s). Seasonal vaccines for influenza are generally inactivated vaccines and are allowed. Intranasal vaccines are live vaccines and are not allowed.
Known untreated or inadequately treated active hepatitis C, or chronic hepatitis B.
Known untreated or inadequately treated human immunodeficiency virus (HIV) infection.
Major surgery within 30 days before the first drug administration. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s).
Prior allogeneic stem cell transplantation or organ transplantation.
Any of the following cardiovascular risk factors:
Acute myocardial infarction ≤6 months before the first dose of study drug(s).
Heart failure meeting New York Heart Association Function Classification III or IV ≤6 months before the first dose of study drug(s)
Ventricular arrhythmia Grade ≥2 in severity ≤6 months before the first dose of study drug(s).
Cerebrovascular accident ≤12 months before the first dose of study drug(s).
Uncontrolled hypertension that cannot be managed by standard antihypertension medications, which is specified as systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg. The participant must have blood pressures below both limits. Repeated assessments are permitted.
Syncope or seizure ≤28 days before the first dose of study drug(s).
Received strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) taken within 2 weeks (or 5 times the t1/2 of the drug, whichever is longer) prior to the first study treatment.
Active gastrointestinal and duodenal ulcers, ulcerative colitis, and other gastrointestinal disease: other conditions that the investigator determines to possibly cause gastrointestinal bleeding, perforation, and other conditions; or prior gastrointestinal perforation or gastrointestinal fistula that has not recovered after surgical treatment.
History or presence of clinically significant hemorrhage from any site (such as clinically significant melena, hematemesis, hemoptysis, fresh in stool) within 2 months before the screening.
History of arterial thrombus within the last 12 months.
What this trial measures
- Safety and adverse events (AEs)Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0