Clinical trial NCT06761027: mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Official title: mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer: A Prospective, Single-arm, Multicenter, Phase Ib/II Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Locally Advanced Pancreatic Cancer
Metastatic Pancreatic Cancer
Keywords: anlotinib
sintilimab
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective, single-arm, multicenter, phase Ib/II clinical trial that treats previously untreated patients with locally advanced or metastatic pancreatic cancer using mFOLFIRINOX in combination with anlotinib and sintilimab. The purpose of this trial is to evaluate the efficacy and safety of this treatment regimen and to preliminarily explore the correlation between biomarkers and treatment outcomes.


Eligibility criteria: Inclusion Criteria:

1. Fully understand this study and voluntarily sign the informed consent form;
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:

1. Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;
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.

Primary outcomes:
measure: Objective response rate, ORR
timeFrame: Four weeks after the initiation of medication until the day before surgery
Secondary outcomes:
measure: Overall survival, OS
timeFrame: From date of enrollment until the date of death from any cause, assessed up to 60 months
measure: Progression free survival, PFS
timeFrame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
measure: Disease control rate, DCR
timeFrame: Four weeks after the initiation of medication until the day before surgery
measure: Toxicity Adverse events
timeFrame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 60 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Fuzhou
country: China
facility: Mengchao Hepatobiliary Hospital of Fujian Medical University
state: Fujian
city: Zhangzhou
country: China
facility: Zhangzhou Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References: