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2024-12-23
2027-03
2027-05
29
NCT06761027
Fujian Provincial Hospital
Fujian Provincial Hospital
INTERVENTIONAL
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
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.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2024-12-28 | N/A | 2025-01-04 |
2025-01-04 | N/A | 2025-01-07 |
2025-01-07 | N/A | 2025-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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 p | DRUG: Anlotinib combined with Sintilimab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate, ORR | 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 | Measure Description | Time Frame |
|---|---|---|
| Overall survival, OS | 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 | 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 | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Mao-Lin Yan Phone Number: 0591-88217140 Email: yanmaolin74@163.com |
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
