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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 (Jun 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 Jun 2026Location: China

Treatment: Fruquintinib, Adebrelimab, Oxaliplatin, CapecitabineTo 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

Treatments studied

Chemotherapy

Fruquintinib, Adebrelimab, Oxaliplatin, Capecitabine

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT06234007 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 CT4B or CN2 is required.

Is there an age limit?

Yes. Patients must be 75 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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