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OncoMatch/Clinical Trials/NCT06405139

Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer

Is NCT06405139 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine for colorectal cancer.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06405139Data as of Jun 2026Location: China

Treatment: Nanoliposomal Irinotecan, Oxaliplatin plus CapecitabineNeoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CT4N1-2M0, CT4BN0M0

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: surgery

Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Cannot have received: chemotherapy

Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Cannot have received: radiotherapy

Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Cannot have received: targeted therapy

Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Cannot have received: immunotherapy

Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.

Lab requirements

Blood counts

Hemoglobin ≥90g/L; WBC ≥3.5×10^9/L; ANC ≥1.5×10^9/L; Platelet count ≥100×10^9/L

Kidney function

Serum creatinine ≤ ULN or creatinine clearance ≥60 ml/min

Liver function

Total serum bilirubin ≤1.5 ULN; AST/SGOT and ALT/SGPT ≤2.5 ULN

Adequate organ function according to the following laboratory test values: Hemoglobin value ≥90g/L. White blood cell count ≥3.5*10^9/L. Absolute neutrophil count ≥1.5*10^9/L. Platelet count ≥100*10^9/L. Serum creatinine ≤ ULN or creatinine clearance ≥60ml/min. Total serum bilirubin ≤1.5 ULN. AST/SGOT and ALT/SGPT ≤2.5 ULN.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06405139 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage CT4N1-2M0 or CT4BN0M0 is required.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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