Combination treatment for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of a combination treatment using mFOLFIRINOX, anlotinib, and sintilimab in patients with locally advanced or metastatic pancreatic cancer who have not received prior treatment. It is a prospective, single-arm, multicenter trial that aims to assess treatment outcomes and explore potential biomarkers associated with the therapy. The study will enroll patients aged 18 to 75 with measurable lesions and an expected survival of at least three months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fujian Provincial Hospital
  Fuzhou, Fujian, China Recruiting
• First Affiliated Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• Mengchao Hepatobiliary Hospital of Fujian Medical University
  Fuzhou, Fujian, China Not yet recruiting
• Zhangzhou Affiliated Hospital of Fujian Medical University
  Zhangzhou, Fujian, China Not yet recruiting

Study contacts

• Study coordinator: Mao-Lin Yan
• Email: yanmaolin74@163.com
• Phone: 0591-88217140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.