Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High… (NCT06228599) | Clinical Trial Compass
RecruitingNot Applicable
Molecular Profile-related Individualized Targeted Therapy in Resected Pancreatic Cancer With High-Risk of Cancer Recurrence
United States40 participantsStarted 2024-02-29
Plain-language summary
This is a prospective, open-label therapeutic interventional investigation designed to interrogate the efficacy and safety of individualized matched therapies in patients with pancreatic cancer at high risk of disease recurrence post-surgery.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥18 years.
✓. Pathologically confirmed pancreatic cancer (excluding neuroendocrine histology).
✓. Pancreatic tumor is surgically removed and
✓. patient has received multimodal therapy (neoadjuvant, sandwich or adjuvant chemotherapy ± radiation) or
✓. patient is ineligible for or refuses multimodal therapy.
✓. Patient has one of the following:
✓. Post-surgical cancer antigen (CA) 19-9 elevation (\> 35 U/mL at least 6 weeks post-surgical resection) in the setting of bilirubin \< 2 mg/dL (unless bilirubin elevation is consistent with Gilbert's syndrome) OR
✓. High-risk pathological features, defined as positive surgical margin or lymph node involvement in cancer.
Exclusion criteria
✕. CA 19-9 non-producers, unless high-risk pathological features present.
✕. Receiving concomitant investigational agent(s) for pancreatic ductal adenocarcinoma (PDAC).
✕. Radiographic evidence of metastatic disease.
✕. Inability to ingest study drugs by mouth.
✕. Diarrheal bowel movements \> 6 per day postoperatively on maximal medical therapy.
What they're measuring
1
Disease-free Survival
Timeframe: Six months
2
Adverse Events
Timeframe: Up to 12 months
Trial details
NCT IDNCT06228599
SponsorMedical College of Wisconsin
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2029-01-31
Contact for this trial
Medical College of Wisconsin Cancer Center Clinical Trials Office
✕. Patient has active, untreated, or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic intravenous therapy.
✕. Patient has undergone or planned major surgery other than diagnostic surgery (i.e., surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of study therapy.
✕. Patient has a history of allergy or hypersensitivity to the study drug(s) or any of the excipients.