mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
NCT ID: NCT06761027
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
29 participants
INTERVENTIONAL
2024-12-23
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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mFOLFIRINOX Plus Anlotinib and Sintilimab
Phase Ib: 6 patients will receive treatment at dose level-0 and their toxicity will be observed. If 2 or fewer patients experience dose-limiting toxicity, the study will proceed to the phase II part using dose level-0 as the treatment dose. If 3 or more patients have dose-limiting toxicity, another 6 patients will be accrued at a lower dose (dose -1). If two or fewer patients have dose-limiting toxicity, then we proceed with the phase II trial at that dose; otherwise, the trial is discontinued.
Dose level - 0: anlotinib at a dose of 10mg per administration, once daily, orally administered on days 1-14, every 3 weeks.
Dose level -1: anlotinib at a dose of 8mg per administration, once daily, orally administered on days 1-14, every 3 weeks.
Phase II: The efficacy and safety of mFOLFIRINOX combined with anlotinib and sintilimab as first-line treatment for locally advanced or metastatic pancreatic cancer will be conducted at the anlotinib safe dose determined in phase Ib.
Anlotinib combined with Sintilimab
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
Interventions
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Anlotinib combined with Sintilimab
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 75 years inclusive, with no gender restrictions;
3. Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;
4. No prior anti-cancer treatment;
5. Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
6. ECOG PS score of 0-1;
7. Expected survival of at least 3 months;
8. No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs;
9. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating, men must agree to use contraceptive measures during the study period and for 6 months after the study ends.
Exclusion Criteria
2. Known allergies to any of the drugs in the study;
3. Symptomatic brain metastases or metastases with symptom control time less than 2 months;
4. A large liver metastasis burden, occupying more than 70% of the liver volume;
5. Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;
6. Presence of any active autoimmune diseases or patients with autoimmune diseases expected to relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);
7. History of immunodeficiency; patients currently using immunosuppressants, systemic corticosteroid therapy, or any other form of immunosuppressive treatment;
8. Known genetic or acquired bleeding tendencies (such as coagulation disorders) or thrombosis, such as hemophiliacs; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed);
9. Serious infections (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 2 weeks before the first use of the study drug, or requiring oral or intravenous antibiotic treatment (excluding the use of antibiotics for prevention);
10. History of other malignant tumors within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma;
11. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction;
12. Pregnant or lactating women;
13. Deemed by the investigator as unsuitable to participate in this trial for other reasons.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Provincial Hospital
OTHER
Responsible Party
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Mao-Lin Yan
Department of Hepatobiliary Pancreatic Surgery
Locations
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First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IEC-SG-029-3.0
Identifier Type: -
Identifier Source: org_study_id
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