mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer

January 4, 2025 updated by: Mao-Lin Yan, Fujian Provincial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Anlotinib combined with Sintilimab
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate, ORR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST v1.1.
Four weeks after the initiation of medication until the day before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival, OS
Time Frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression free survival, PFS
Time Frame: 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
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
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
Disease control rate, DCR
Time Frame: Four weeks after the initiation of medication until the day before surgery
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to RECIST v1.1.
Four weeks after the initiation of medication until the day before surgery
Toxicity Adverse events
Time Frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 60 months
Grade 1-5 AEs according to NCI-CTCAE V5.0.
From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

December 28, 2024

First Submitted That Met QC Criteria

January 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 4, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC-SG-029-3.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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