Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borde… (NCT07469956) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer
China30 participantsStarted 2026-03-31
Plain-language summary
The goal of this clinical trial is to learn if surufatinib (VEGFR-TKI) plus toripalimab (PD-1 inhibitor) and mFOLFIRINOX (chemotherapy) works as neoadjuvant therapy for patients with high-risk or borderline resectable pancreatic cancer. It will also learn about the safety of the combination regimen. The main questions it aims to answer are:
Does the treatment regimen of surufatinib combined with immunotherapy and chemotherapy could provide further survival benefits for patients with high-risk resectable or borderline resectable pancreatic cancer as neoadjuvant therapy?
Is the safety of this combination therapy tolerable?
Participants will:
Take surufatinib (200mg, qd, po, q2w), Toripalimab (3mg/kg, iv, d1, q2w), Oxaliplatin (68 mg/m², iv, d1, q2w), Irinotecan (135 mg/m², iv, d1, q2w), Calcium folinate (400 mg/m², iv, d1, q2w), 5-FU (2400 mg/m², iv). Treatment for up to 8 cycles.
Visit the clinic once every 8 weeks (± 7 days) for checkups and tests. Keep a diary of their symptoms and record daily medication doses.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily sign the informed consent form.
✓. Ages 18-75 years, no gender restrictions.
✓. Patients with high-risk resectable or borderline resectable pancreatic cancer confirmed by pathological tissue or cytology:
✓. The patient must have at least one measurable lesion (RECIST 1.1).
✓. No BRCA1/2 or PALB2 mutations.
✓. Has not previously received systemic therapy or local radiotherapy.
✓. ECOG performance status 0-1;
✓. Expected survival ≥24 weeks;
Exclusion criteria
✕. Patients with distal metastasis;
✕. Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
What they're measuring
1
12-month Event Free Survival Rate
Timeframe: From enrollment to the end of observation at 12 months
. Received any surgical or invasive treatment or operation within 4 weeks prior to enrollment (except for intravenous catheterization, puncture and drainage, etc.);
✕. Known allergy to any drug in the study;
✕. Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
✕. The patient currently has any disease or condition that affects the absorption of the drug, or the patient has difficulty swallowing and cannot take surufatinib orally;
✕. Patients currently have active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
✕. Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture methods as judged by the investigator);