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OncoMatch/Clinical Trials/NCT06800391

Metronomic Neoadjuvant Capecitabine and Cyclophosphamide in HUGE Pseudomyxoma Peritonei Patients

Is NCT06800391 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/day for pseudomyxoma peritonei.

Phase 2RecruitingFondazione IRCCS Istituto Nazionale dei Tumori, MilanoNCT06800391Data as of May 2026

Treatment: Capecitabine 1250 mg/m2 /day - Cyclophosphamide 50Mg/dayThe goal of this clinical trial is to evaluate the safety and efficacy of neoadjuvant capecitabine and cyclophosphamide treatment in patients affected by huge Pseudomyxoma peritonei (PMP) (peritoneal cancer index \>28). Treatment consists of metronomic (low-dose medication for a prolonged time) of capecitabine plus cyclophosphamide for 6 months followed by standard of care cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC). The main question the trial aims to answer is which is the proportion of patients with complete cytoreduction at CRS/HIPEC after neoadjuvant metronomic approach with oral capecitabine and cyclophosphamide in patients affected by huge PMP.

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Extracted eligibility criteria

Biomarker criteria

Excluded: DPYD deficiency

DPD deficiency

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: systemic chemotherapy

Previous systemic chemotherapy

Cannot have received: biological therapy

Previous...biological therapy

Lab requirements

Blood counts

wbc count >3.0x109/l, absolute neutrophyl count >1.5x109/l, platelet count >100x109/l, and hemoglobin >10 g/dl

Kidney function

creatinine clearance >50 ml/min or serum creatinine <1.5 x unl

Liver function

bilirubin < 1.5 times the uln, alkaline phosphatase, aspartate transaminase, and alanine transaminase < 2.5 x uln

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

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