A Phase 2 Trial of Fruquintinib and Tislelizumab in ctDNA-defined Minimal Residual Disease in Colorectal Cancer After Completion of Adjuvant Chemotherapy

NCT07136077 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0696NCI-2025-06047
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Minimal Residual Disease; Adjuvant Chemotherapy; Colorectal Cancer; Fruquintinib; Tislelizumab; ctDNA

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Phase II: Treatment with Fruquintinib and Tislelizumab

EXPERIMENTAL

Treatment with Fruquintinib and Tislelizumab

Drug: Tislelizumab; Drug: Fruquintinib

Interventions

Tislelizumab DRUG

Given by IV

Phase II: Treatment with Fruquintinib and Tislelizumab

Fruquintinib DRUG

Give by PO

Phase II: Treatment with Fruquintinib and Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• BeiGene: collaborator
• Takeda Pharmaceutical Co. Limited: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasm, Residual; Colorectal Neoplasms

Interventions

tislelizumab; HMPL-013

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Arvind Dasari, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arvind Dasari, MD

CONTACT

713-792-2828; giclinicaltrials@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 22, 2025
• Study Start: September 18, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 1, 2026

Record last verified: 2025-08

Locations

US (1)