Locally Advanced Pancreatic CancerPhase 1/2NCT06761027
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
A Phase 1/2 study testing Anlotinib combined with Sintilimab in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Fujian Provincial Hospital at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Anlotinib combined with Sintilimab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesChina
- Study dates
- 23 Dec 2024to May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fully understand this study and voluntarily sign the informed consent form;
- Age between 18 and 75 years inclusive, with no gender restrictions;
- Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;
- No prior anti-cancer treatment;
- Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
- ECOG PS score of 0-1;
Show all 9Show fewer
- Expected survival of at least 3 months;
- No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs;
- 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.
Who cannot join
- Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;
- Known allergies to any of the drugs in the study;
- Symptomatic brain metastases or metastases with symptom control time less than 2 months;
- A large liver metastasis burden, occupying more than 70% of the liver volume;
- Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;
- 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);
Show all 13Show fewer
- History of immunodeficiency; patients currently using immunosuppressants, systemic corticosteroid therapy, or any other form of immunosuppressive treatment;
- 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);
- 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);
- 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;
- Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction;
- Pregnant or lactating women;
- Deemed by the investigator as unsuitable to participate in this trial for other reasons.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Zhi-Bo Zhang, 13960986516, zbzhang_1234@163.com
- Recruiting
Fujian Provincial Hospital
Fuzhou, Fujian
Mao-Lin Yan, 0591-88217140, yanmaolin74@163.com
- Not yet recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian
Yong-Yi Zeng, 13805083802, lamp197311@126.com
- Not yet recruiting
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian
Yu-Feng Chen, 18906963008, drcyf0103@163.com
About this study
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
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.
- Being tested
- Anlotinib combined with Sintilimab
- Keywords
- anlotinib, sintilimab
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib combined with SintilimabDrug
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
| Study group | Role | What they receive |
|---|---|---|
| mFOLFIRINOX Plus Anlotinib and Sintilimab | Experimental | 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. Receives: Drug: Anlotinib combined with Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four weeks after the initiation of medication until the day before surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start23 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Provincial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mao-Lin Yan, Fujian Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761027
- Sponsor's protocol ID
- IEC-SG-029-3.0
- Status last verified
- Jan 2025
- First submitted
- 28 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06761027
- Acronym / sponsor ID
- IEC-SG-029-3.0
- Keywords
- anlotinib, sintilimab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Fujian Provincial HospitalUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mFOLFIRINOX Plus Anlotinib and Sintilimab | Experimental | Drug: Anlotinib combined with SintilimabPhase 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand this study and voluntarily sign the informed consent form;
- Age between 18 and 75 years inclusive, with no gender restrictions;
- Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;
- No prior anti-cancer treatment;
- Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
Key exclusion criteria (13 listed)
- Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;
- Known allergies to any of the drugs in the study;
- Symptomatic brain metastases or metastases with symptom control time less than 2 months;
- A large liver metastasis burden, occupying more than 70% of the liver volume;
- Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anlotinib combined with SintilimabBased on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab. | Drug | mFOLFIRINOX Plus Anlotinib and Sintilimab |
Primary outcome
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.
4 secondary outcomes
Overall survival, OS
Time frame: 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
Disease control rate, DCR
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
Related trials for Locally Advanced Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Anlotinib combined with Sintilimab in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Fujian Provincial Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mao-Lin Yan (0591-88217140, yanmaolin74@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate, ORR (time frame: Four weeks after the initiation of medication until the day before surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.