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New triple therapy aims to shrink pancreatic tumors before surgery

NCT ID NCT07469956

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests whether giving a combination of surufatinib (a targeted therapy), toripalimab (an immunotherapy), and chemotherapy before surgery can help people with high-risk or borderline resectable pancreatic cancer. The study will enroll 30 participants and track how many are free of cancer events after 12 months. The goal is to see if this approach makes tumors easier to remove and improves survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
surufatinib, toripalimab, and chemotherapy (mFOLFIRINOX)
What this could lead to
If this works, it could shrink pancreatic tumors enough to allow successful surgery, potentially improving long-term survival for patients with hard-to-treat pancreatic cancer.
What could go wrong
This is a small, early-phase trial with only 30 people, so results may not apply broadly. The combination of drugs can cause serious side effects, and it is not yet known if it will improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily sign the informed consent form. 2. Ages 18-75 years, no gender restrictions. 3. 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. 4. The patient must have at least one measurable lesion (RECIST 1.1). 5. No BRCA1/2 or PALB2 mutations. 6. Has not previously received systemic therapy or local radiotherapy. 7. ECOG performance status 0-1; 8. Expected survival ≥24 weeks; 9. No surgical contraindications; 10. 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; 11. 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). Exclusion Criteria: 1. Patients with distal metastasis; 2. Received blood transfusion therapy, blood products and hematopoietic factors such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment; 3. Received any surgical or invasive treatment or operation within 4 weeks prior to enrollment (except for intravenous catheterization, puncture and drainage, etc.); 4. Known allergy to any drug in the study; 5. Presence of hypertension that cannot be controlled by medication, as prescribed as: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg; 6. 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; 7. 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; 8. Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture methods as judged by the investigator); 9. 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; 10. Clinically significant electrolyte abnormalities judged by the investigator; 11. 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%; 12. 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; 13. 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;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.