OncoMatch/Clinical Trials/NCT06234007

Short-course Radiotherapy Followed by Fruquintinib Plus Adebrelimab and CAPOX in the Full Course Neoadjuvant Treatment of Locally Advanced Rectal Cancer: a Multicenter, Single-arm, Open-label Study

Is NCT06234007 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine for locally advanced rectal cancer.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT06234007Data as of May 2026

Treatment: Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine — To investigate the efficacy and safety of short-course radiotherapy sequential fruquintinib in combination with adebrelimab and CAPOX (full course neoadjuvant therapy) in patients with locally advanced rectal cancer.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Disease stage

Required: Stage CT4B, CN2 (AJCC 8th edition)

Clinical tumor (cT) stage cT4a or cT4b (according to the AJCC, 8th edition); Clinical lymph node (cN) stage cN2 (according to the AJCC, 8th edition)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

Cannot have received: any anti-tumor treatment

Have not received any anti-tumor treatment for rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.

Lab requirements

Blood counts

Neutrophil count ≥ 1.5×10^9/L; Platelet count ≥ 100×10^9/L; Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.0×10^9/L

Kidney function

Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 50 mL/min (Cocheroft-Gault formula)

Liver function

Total bilirubin ≤ 1.5×ULN (Gilbert's syndrome subjects, ≤3×ULN; Tumor liver metastasis, total bilirubin ≤3×ULN); ALT ≤ 2.5×ULN, AST ≤ 2.5×ULN (≤5×ULN for patients with liver metastases)

Cardiac function

Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%

Normal major organ function, including: Routine blood test ...; Blood biochemical tests ...; Coagulation function ...; Doppler ultrasound assessment: left ventricular ejection fraction (LVEF)≥50%

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

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