Not Yet RecruitingPhase 2

A Clinical Study of Iparomlimab and Tuvonralimab Combined With Fruquintinib and Heterogeneous Radiotherapy Versus Fruquintinib as Third-Line and Subsequent-Line Treatment for Metastatic Colorectal Cancer

60 participantsStarted 2026-05-01

Plain-language summary

This is a randomized, parallel, open-label, multicenter exploratory clinical study designed to investigate the efficacy and safety of iparomlimab and tuvonralimab in combination with fruquintinib plus heterogeneous radiotherapy, compared with fruquintinib monotherapy, as the third-line and subsequent-line treatment for patients with oligometastatic colorectal cancer.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10⁹/L, white blood cell (WBC) count ≥4.0×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L.
✓. Hepatic function: Serum total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN). If serum total bilirubin level \>1.5×ULN, direct bilirubin level must be ≤ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (up to 5×ULN for patients with liver metastases).
✓. Renal function: Blood urea nitrogen (BUN) and serum creatinine (Cr) ≤1.5×ULN (with creatinine clearance rate (CCr) ≥50 mL/min).
✓. Cardiac function: Normal cardiac function with left ventricular ejection fraction (LVEF) ≥50%.
✓. Coagulation function: International normalized ratio (INR) ≤1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN.

Exclusion criteria

✕. New York Heart Association (NYHA) Class ≥II cardiac insufficiency or LVEF \<50% on echocardiography;
✕. Unstable angina;
✕. Myocardial infarction within 1 year prior to initiation of study treatment;
✕. Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention;
✕. QTc interval \>450 ms (males) or \>470 ms (females) calculated by Fridericia formula. (If QTc is abnormal, three consecutive measurements at 2-minute intervals may be performed and averaged.)

What they're measuring

Progression-Free Survival

Timeframe: From date of subject's enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

Trial details

NCT IDNCT07502014

SponsorHuazhong University of Science and Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Metastatic Colorectal Cancer (CRC) trials