OncoMatch/Clinical Trials/NCT06300489
Genotype-driven Weekly Irinotecan Liposomes in Combination With Capecitabine-based Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Is NCT06300489 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies irinotecan liposomes+capecitabine for rectal cancer.
Treatment: irinotecan liposomes+capecitabine — This study is a multicenter, open, and phase I dose increasing clinical study. Based on the UGT1A1 \* 28 and \* 6 genotypes of patients with locally advanced rectal cancer, determine the dose limiting toxicity (DLT) and maximum tolerable dose (MTD) of weekly irinotecan liposomes in concurrent chemoradiotherapy with capecitabine, investigate the tolerance of irinotecan liposome combined with capecitabine in concurrent chemoradiotherapy with locally advanced rectal cancer, and recommend the dosage for Phase II clinical study，and explore the pharmacokinetic characteristics of irinotecan liposomes combined with capecitabine.At the same time，Preliminary observe the efficacy and safety of irinotecan liposomes combined with capecitabine in chemoradiotherapy.The study plans to recruit 30 patients with advanced rectal cancer who have not received any therapy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR proficient (pMMR)
immunohistochemical pMMR
Required: MSI low (MSI-L)
MSI-L
Required: MSI stable (MSS)
MSS
Required: UGT1A1 *6 and *28 wild-type (GG+6/6), single site mutant (GG+6/7 or GA+6/6), or dual site mutant (GG+7/7 or AA+6/6 or GA+6/7)
UGT1A1 * 6 and UGT1A1 * 28 gene phenotypes are all wild-type (GG+6/6), unit point mutant (GG+6/7 or GA+6/6), and dual site mutant (GG+7/7 or AA+6/6 or GA+6/7)
Excluded: MMR deficient
immunohistochemical dMMR
Excluded: MSI high
MSI-H
Excluded: UGT1A1 *6 and *28 three site mutations (AA+7/7 or AA+6/7 or GA+7/7)
UGT1A1 * 6, UGT1A1 * 28 gene phenotype three site mutations (AA+7/7 or AA+6/7 or GA+7/7)
Excluded: DPYD deficiency
dihydropyrimidine dehydrogenase (DPD) deficiency
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; Serum albumin ≥ 30g/L
Kidney function
Serum creatinine <1 times the upper normal limit value
Liver function
ALT and AST ≤ 2.5 times the normal upper limit value; ALP ≤ 2.5 times the normal upper limit value; Serum total bilirubin <1.5 times the upper normal limit value
The baseline blood routine and biochemical indicators of the subjects do not meet the following criteria: hemoglobin ≥ 90g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelets ≥ 100 × 10^9/L; ALT and AST ≤ 2.5 times the normal upper limit value; ALP ≤ 2.5 times the normal upper limit value; Serum total bilirubin <1.5 times the upper normal limit value; Serum creatinine <1 times the upper normal limit value; Serum albumin ≥ 30g/L
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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