Pancreatic Cancer ResectablePhase 2NCT07469956

Surufatinib Plus mFOLFIRINOX and PD-1 Inhibitor as the Neoadjuvant Therapy for High-risk or Borderline Resectable Pancreatic Cancer

A Phase 2 study testing Surufatinib, Toripalimab and mFOLFIRINOX in people with Pancreatic Cancer Resectable, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

The goal of this clinical trial is to learn if surufatinib (VEGFR-TKI) plus toripalimab (PD-1 inhibitor) and mFOLFIRINOX (chemotherapy) works as neoadjuvant therapy for patients with high-risk or borderline resectable pancreatic cancer. It will also learn about the safety of the combination regimen. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Pancreatic Cancer Resectable
What is being tested?: Surufatinib, Toripalimab and mFOLFIRINOX
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteChina
Study dates: 31 Mar 2026to 31 Jan 2029
Phase: Phase 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

Voluntarily sign the informed consent form.
Ages 18-75 years, no gender restrictions.
Patients with high-risk resectable or borderline resectable pancreatic cancer confirmed by pathological tissue or cytology:
High-risk features include: ① Imaging findings; ② Significant elevation of CA 19-9 (baseline >210 U/ml, Vincent P Groot, Ann Surg. 2019 Jun;269(6):1154-1162); ③ Large primary tumor (>3 cm, Vincent P Groot, Ann Surg. 2019 Jun;269(6):1154-1162); ④ Large regional lymph nodes (it is recommended to use imaging to assess lymph node metastasis, or if the number of metastatic lymph nodes >3, N2 stage); ⑤ Excessive weight loss (more than 5 kg within 1 month); ⑥ Severe pain (main complaint of abdominal pain is sufficient).
Definition of borderline resectable: ① Arteries: Tumor contact with the celiac trunk (≤180°) or superior mesenteric artery (SMA) (≤180°), or involvement of the hepatic artery that is reconstructable. ② Veins: Narrowing or occlusion of the superior mesenteric vein (SMV)/portal vein (PV), but the proximal/distal vessels are suitable for reconstruction.
The patient must have at least one measurable lesion (RECIST 1.1).

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No BRCA1/2 or PALB2 mutations.
Has not previously received systemic therapy or local radiotherapy.
ECOG performance status 0-1;
Expected survival ≥24 weeks;
No surgical contraindications;
Blood tests (without transfusion in the past 14 days) 1) Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin concentration ≥9 g/dL; 2) Liver function tests (AST and ALT ≤2.5×ULN, total bilirubin ≤1.5×ULN; if there are liver metastases, AST and ALT ≤5×ULN); 3) Kidney function (serum creatinine ≤1.5×ULN, creatinine clearance (CCr) ≥60 ml/min); 4) Coagulation, international normalized ratio (INR) ≤1.5×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN;
Male or female patients of reproductive potential voluntarily use effective contraception during the study period and for 6 months after the last study treatment, such as dual-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered of reproductive potential unless the female patient is naturally menopausal, has undergone induced menopause, or has had sterilization procedures (such as hysterectomy, bilateral salpingo-oophorectomy, or ovarian irradiation).

Who cannot join

Patients with distal metastasis;
Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
Received any surgical or invasive treatment or operation within 4 weeks prior to enrollment (except for intravenous catheterization, puncture and drainage, etc.);
Known allergy to any drug in the study;
Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
The patient currently has any disease or condition that affects the absorption of the drug, or the patient has difficulty swallowing and cannot take surufatinib orally;

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Patients currently have active gastric and duodenal ulcers, ulcerative colitis and other gastrointestinal diseases or active bleeding from unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture methods as judged by the investigator);
Patients with obvious evidence or history of bleeding tendency within 3 months before enrollment (bleeding >30 mL within 3 months, with hematemesis, black feces, blood in the stool), hemoptysis (>5 mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 10 months;
Clinically significant electrolyte abnormalities judged by the investigator;
Significant clinically significant cardiovascular disease, including but not limited to the following: acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure New York Heart Association (NYHA) grade >2; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) < 50%;
Other malignant tumors within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
Active or uncontrolled serious infection:
1) Known human immunodeficiency virus (HIV) infection; 2) Known history of clinically significant liver disease, including viral hepatitis [for known hepatitis B virus (HBV) carriers, active HBV infection must be excluded, i.e., HBV DNA positive (>1×10^4 copies/mL or >2000 IU/mL)]; 3) Known hepatitis C virus (HCV) infection with HCV RNA positive (>1×10^3 copies/mL), or other hepatitis, cirrhosis; 14. Women who are pregnant (tested positive for pregnancy before taking the medication) or are currently breastfeeding; 15. Subjects whom the investigator considers unsuitable for participation in this clinical study due to any clinical or laboratory abnormalities or other reasons; 16. Those with routine urine test indicating urinary protein ≥2, and 24-hour urine protein quantification >1.0g;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhiqiang Wang, Phd contact

020-87343289

wangzhq@sysucc.org.cn

China1 site

Sun Yat-sen University Cancer Center
Guangzhou
Zhiqiang Wang, Phd, 020-87343289, wangzhq@sysucc.org.cn
Zhiqiang Wang, Phd

Other trials in China

About this study

Official title: Neoadjuvant Therapy With Surufatinib Combined With mFOLFIRINOX and Toripalimab for High-risk or Borderline Resectable Pancreatic Cancer: A Phase II, Single-arm, Single-center Study

Does the treatment regimen of surufatinib combined with immunotherapy and chemotherapy could provide further survival benefits for patients with high-risk resectable or borderline resectable pancreatic cancer as neoadjuvant therapy?

Is the safety of this combination therapy tolerable?

Participants will:

Take surufatinib (200mg, qd, po, q2w), Toripalimab (3mg/kg, iv, d1, q2w), Oxaliplatin (68 mg/m², iv, d1, q2w), Irinotecan (135 mg/m², iv, d1, q2w), Calcium folinate (400 mg/m², iv, d1, q2w), 5-FU (2400 mg/m², iv). Treatment for up to 8 cycles.

Visit the clinic once every 8 weeks (± 7 days) for checkups and tests. Keep a diary of their symptoms and record daily medication doses.

Read the detailed description

This study is a single-center, single-arm, phase II study.

Preoperative neoadjuvant treatment plan:

Surufatinib: 200 mg orally once daily, continuous dosing, with a 14-day treatment cycle;
Toripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour on day 1, every 14 days per treatment cycle;
Oxaliplatin: 68 mg/m² intravenous infusion over 2 hours on day 1;
Irinotecan: 135 mg/m² intravenous infusion over 30-90+ minutes on day 1;
Calcium folinate: 400 mg/m² intravenous infusion over 2 hours on day 1;
5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; repeated every 14 days per treatment cycle.

Neoadjuvant treatment will be administered for up to 8 cycles. During treatment, tumor assessments using imaging will be conducted every 8 weeks (±7 days). For patients achieving stable disease, partial response, or complete response, it will be evaluated whether surgery is feasible. Surgery should occur at least 2 weeks after the last neoadjuvant treatment.

Postoperative adjuvant treatment plan:

Adjuvant treatment will begin within 4-8 weeks after surgery, with the specific regimen determined by the investigator.
During postoperative adjuvant treatment, tumor assessments using imaging will be conducted every 8 weeks (±7 days) until disease progression (RECIST 1.1) or death (during patient treatment), or until intolerable toxicity occurs. Subsequent treatment after disease progression and survival status will also be recorded.

Conditions: Pancreatic Cancer Resectable
Being tested: Surufatinib, Toripalimab, mFOLFIRINOX
Keywords: Surufatinib, Toripalimab, Pancreatic cancer, Resectable
Medical subject headings: Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SurufatinibDrug
Surufatinib: 200 mg orally once daily, continuous dosing, with each 14 days as one treatment cycle
ToripalimabDrug
Toripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour, on day 1, with each 14 days as one treatment cycle
mFOLFIRINOXDrug
Oxaliplatin: 68 mg/m² intravenous infusion over 2 hours, on day 1; Irinotecan: 135 mg/m² intravenous infusion over more than 30-90 minutes, on day 1; Calcium folinate: 400 mg/m² intravenous infusion over 2 hours, on day 1; 5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; With each 14 days as one treatment cycle; Neoadjuvant treatment for up to 8 cycles.

Study groups in NCT07469956
Study group	Role	What they receive
Surufatinib + Toripalimab + mFOLFIRINOX	Experimental	Not described Receives: Drug: Surufatinib; Drug: Toripalimab; Drug: mFOLFIRINOX

What is being measured

The primary outcome is the main question the study is designed to answer.

12-month Event Free Survival Rate
Event-free survival (EFS) is defined as the time from enrollment to the first occurrence of any of the following events, including (1) disease progression according to RECIST criteria, (2) undergoing R2 resection surgery, (3) disease recurrence after surgery, or (4) death from any cause.
The 12-month EFS rate is defined as the proportion of patients among the total enrolled who have not experienced any of the above predefined events within 12 months from enrollment.
Measured: From enrollment to the end of observation at 12 months

Secondary outcomes (6)

R0 Resection Rate
The proportion of patients whose postoperative pathological evaluation shows no residual tumor cells at all surgical margins (R0) among all patients who underwent surgery after receiving neoadjuvant therapy.
Measured: From enrollment to the end of treatment for up to 16 weeks
Objective Response Rate
Refers to the proportion of patients whose tumors shrink by a certain amount and maintain it for a certain period of time, including cases of CR and PR. The objective response rate is evaluated using the RECIST 1.1. Subjects must have measurable tumor lesions at enrollment, and the efficacy evaluation criteria according to RECIST 1.1 are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).
Measured: From enrollment to the end of treatment for up to 16 weeks
Disease Control Rate
Refers to the percentage of patients with complete response, partial response, and stable disease maintained for more than 4 weeks among those evaluable for efficacy.
Measured: From enrollment to the end of treatment for up to 16 weeks
Recurrence Free Survival
Recurrence-free survival (RFS) refers to the time interval from the date of surgery following neoadjuvant therapy to the recurrence of the tumor (including local/regional recurrence or distant metastasis) or death from any cause.
Measured: From the date of surgery at week 18 to the recurrence of the tumor or death for up to 96 weeks.
Overall Survival
Overall survival (OS) refers to the time from enrollment to the date of death from any cause.
Measured: From enrollment to the date of death from any cause for up to 96 weeks.
AEs
Collect adverse events (AEs) from enrollment to 30 days after the end of treatment, and grade the AEs according to CTCAE 5.0.
Measured: From enrollment to 30 days after the end of treatment at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Mar 202631 Jan 2029

First posted13 Mar 2026
Study start31 Mar 2026 (estimated)
Primary completion31 Jan 2028 (estimated)
Study completion31 Jan 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pancreatic Cancer ResectableStudies of the same condition, open and under way.
More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single-center, single-arm, Phase II study
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07469956
Sponsor's protocol ID: HMPL-012-SPRING-P108
Status last verified: Mar 2026
First submitted: 11 Feb 2026
Last updated: 13 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Zhiqiang Wang, Phd

020-87343289

wangzhq@sysucc.org.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer
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Not yet recruitingPhase 1/2
A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer
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All Pancreatic Cancer Resectable trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Therapy With Surufatinib Combined With mFOLFIRINOX and Toripalimab for High-risk or Borderline Resectable Pancreatic Cancer: A Phase II, Single-arm, Single-center Study
ClinicalTrials.gov ID: NCT07469956
Acronym / sponsor ID: HMPL-012-SPRING-P108
Conditions: Pancreatic Cancer Resectable
Keywords: Surufatinib, Toripalimab, Pancreatic cancer, Resectable
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Sun Yat-sen UniversityUniversity, hospital or other
Study start: 31 Mar 2026 (estimated)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Jan 2029 (estimated)
First posted: 13 Mar 2026 (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.

Is the safety of this combination therapy tolerable?

Participants will:

Visit the clinic once every 8 weeks (± 7 days) for checkups and tests. Keep a diary of their symptoms and record daily medication doses.

Detailed description

This study is a single-center, single-arm, phase II study.

Preoperative neoadjuvant treatment plan:

Surufatinib: 200 mg orally once daily, continuous dosing, with a 14-day treatment cycle;
Toripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour on day 1, every 14 days per treatment cycle;
Oxaliplatin: 68 mg/m² intravenous infusion over 2 hours on day 1;
Irinotecan: 135 mg/m² intravenous infusion over 30-90+ minutes on day 1;
Calcium folinate: 400 mg/m² intravenous infusion over 2 hours on day 1;
5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; repeated every 14 days per treatment cycle.

Postoperative adjuvant treatment plan:

Adjuvant treatment will begin within 4-8 weeks after surgery, with the specific regimen determined by the investigator.
During postoperative adjuvant treatment, tumor assessments using imaging will be conducted every 8 weeks (±7 days) until disease progression (RECIST 1.1) or death (during patient treatment), or until intolerable toxicity occurs. Subsequent treatment after disease progression and survival status will also be recorded.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single-center, single-arm, Phase II study

Arm	Type	Receives
Surufatinib + Toripalimab + mFOLFIRINOX	Experimental	Drug: Surufatinib, Drug: Toripalimab, Drug: mFOLFIRINOX

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Voluntarily sign the informed consent form.
Ages 18-75 years, no gender restrictions.
Patients with high-risk resectable or borderline resectable pancreatic cancer confirmed by pathological tissue or cytology:
The patient must have at least one measurable lesion (RECIST 1.1).
No BRCA1/2 or PALB2 mutations.

Key exclusion criteria (14 listed)

Patients with distal metastasis;
Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
Received any surgical or invasive treatment or operation within 4 weeks prior to enrollment (except for intravenous catheterization, puncture and drainage, etc.);
Known allergy to any drug in the study;
Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;

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
SurufatinibSurufatinib: 200 mg orally once daily, continuous dosing, with each 14 days as one treatment cycle	Drug	Surufatinib + Toripalimab + mFOLFIRINOX
ToripalimabToripalimab: 3 mg/kg per dose, intravenous infusion over 1 hour, on day 1, with each 14 days as one treatment cycle	Drug	Surufatinib + Toripalimab + mFOLFIRINOX
mFOLFIRINOXOxaliplatin: 68 mg/m² intravenous infusion over 2 hours, on day 1; Irinotecan: 135 mg/m² intravenous infusion over more than 30-90 minutes, on day 1; Calcium folinate: 400 mg/m² intravenous infusion over 2 hours, on day 1; 5-FU: 2400 mg/m² continuous intravenous infusion over 46 hours; With each 14 days as one treatment cycle; Neoadjuvant treatment for up to 8 cycles.	Drug	Surufatinib + Toripalimab + mFOLFIRINOX

Primary outcome

12-month Event Free Survival Rate
Time frame: From enrollment to the end of observation at 12 months
Event-free survival (EFS) is defined as the time from enrollment to the first occurrence of any of the following events, including (1) disease progression according to RECIST criteria, (2) undergoing R2 resection surgery, (3) disease recurrence after surgery, or (4) death from any cause. The 12-month EFS rate is defined as the proportion of patients among the total enrolled who have not experienced any of the above predefined events within 12 months from enrollment.

6 secondary outcomes

R0 Resection Rate
Time frame: From enrollment to the end of treatment for up to 16 weeks
Objective Response Rate
Time frame: From enrollment to the end of treatment for up to 16 weeks
Disease Control Rate
Time frame: From enrollment to the end of treatment for up to 16 weeks
Recurrence Free Survival
Time frame: From the date of surgery at week 18 to the recurrence of the tumor or death for up to 96 weeks.
Overall Survival
Time frame: From enrollment to the date of death from any cause for up to 96 weeks.
AEs
Time frame: From enrollment to 30 days after the end of treatment at 16 weeks

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 13 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Pancreatic Cancer Resectable

Recruiting
CREO - Microwave Ablation Feasibility Study
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RecruitingPhase 1
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RecruitingPhase 2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
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RecruitingPhase 2
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Not yet recruitingPhase 1/2
A Study of Perioperative Navlimetostat Combined With Modified FOLFIRINOX in Patients With MTAP-Deleted Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Zhiqiang Wang, Phd contact

020-87343289

wangzhq@sysucc.org.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib, Toripalimab and mFOLFIRINOX in people with Pancreatic Cancer Resectable, run by Sun Yat-sen University at 1 site 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 13 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 phase mean?

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 Zhiqiang Wang, Phd (020-87343289, wangzhq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12-month Event Free Survival Rate (time frame: From enrollment to the end of observation at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07469956.

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 13 Mar 2026.