New cocktail of drugs takes on tough pancreatic cancer
NCT ID NCT05481476
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times
Summary
This phase 2 trial is testing a combination of three drugs—surufatinib, sintilimab, and a standard chemotherapy (nab-paclitaxel plus gemcitabine)—as a first treatment for people with advanced or metastatic pancreatic cancer. The study enrolled 32 participants and aims to see how many respond to the treatment. It is active but no longer recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surufatinib, sintilimab, nab-paclitaxel, gemcitabine
- What this could lead to
- If successful, this combination could offer a new first-line treatment option for advanced pancreatic cancer, potentially slowing disease progression.
- What could go wrong
- This is a small, early-phase trial with only 32 participants and no comparison group. The combination may cause significant side effects and may not prove more effective than standard therapy.
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 32 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2022
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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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 Hide 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. Informed consent has been signed 2. Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer 3. Age ≥ 18 years, ≤75 years, male or female 4. ECOG PS:0-1, expected overall survival ≥12 months 5. Patients who have not previously received systemic therapy for locally advanced or metastatic pancreatic cancer 6. Patients with distant metastases after surgery, who have received one regimen of adjuvant chemotherapy and have recurred \> 6 months from adjuvant therapy can be enrolled 7. Patients must have at least one measurable liver metastases (RECIST 1.1) 8. No serious organic diseases of the heart, lungs, brain and other organs 9. Patients must have adequate organ and bone marrow function 10. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration Exclusion Criteria: 1. Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment 2. Previously received VEGFR inhibitors or immune checkpoint inhibitors 3. Patients with BRCA1/2 germline mutations 4. Patients with obstructive jaundice but less than expected jaundice 5. Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ 6. Patients previously had brain metastasis or current brain metastasis 7. Investigator determines that the liver metastases account for 70% or more of the total liver volume 8. Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment 9. Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases within 4 weeks before enrollment 10. Clinically significant electrolyte abnormality 11. Patient currently has uncontrolled hypertension, defined as: systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg 12. Proteinuria ≥ 2+ (1.0g/24hr) 13. Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study period as judged by the investigator 14. Have evidence or history of bleeding tendency within 3 months, Significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment 15. Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification \> 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval ≥ 480 ms 16. Active or uncontrolled serious infection (≥CTCAE grade 2 infection) 17. Unrelieved toxic reactions ≥ CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of ≤ grade 2 caused by oxaliplatin 18. Pregnant or lactating women 19. Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk 20. Clinical confirmed human immunodeficiency virus (HIV) infection, history of clinically significant liver disease, including viral hepatitis (hepatitis B / C (HBV DNA Positive\[1×104 copies/mL or \>2000 IU/ml\], HCV RNA positive\[\>1×103 copies/mL\]), or other hepatitis, cirrhosis\]) 21. Patients with autoimmune disease or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple Sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.) 22. Patients who are allergic or suspected to be allergic to the study drug or similar drugs 23. Patients have other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities. Accompanied by family or social factors, which will affect the safety of patients
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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.
Contacts and locations
Locations
-
Cancer center of SunYat-sen University
Guangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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