Surufatinib with Gemcitabine and Nab-paclitaxel as Neoadjuvant Therapy for High-Risk or Borderline Resectable Pancreatic Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study compares two neoadjuvant regimens for adults with high-risk resectable or borderline resectable pancreatic cancer. Participants are assigned to receive surufatinib plus gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone before surgery, with safety and efficacy outcomes monitored. Eligibility requires confirmed pancreatic cancer, good performance status, measurable disease, and no prior pancreatic cancer therapy. Exclusion criteria include distant metastasis, recent major procedures, and certain transfusion or allergic conditions. The trial is led by Tianjin Medical University Cancer Institute and Hospital in Tianjin, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically or cytologically confirmed high-risk resectable or borderline resectable pancreatic cancer;
* 18-75 years old (including 18 and 75 years old);
* No BRCA1/2 or PALB2 mutation;
* No previous pancreatic cancer resection, systemic therapy, or local radiation therapy;
* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
* Life expectancy ≥ 6 months;
* At least one measurable lesion according to RECIST version 1.1;
* Adequate organ and bone marrow functions;
* Women of childbearing age need to take effective contraceptive measures.

Exclusion Criteria:

* With distant metastasis;
* Have received blood transfusion treatment, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF) within 14 days before enrollment;
* Have received any surgery or invasive treatment or operation within 4 weeks before enrollment (except venous catheterization, puncture and drainage, etc.);
* Allergic to the study drug or any of its adjuvants;
* Researchers judged clinically significant electrolyte abnormalities;
* History of serious cardiovascular and cerebrovascular diseases;
* With active ulcer, intestinal perforation and intestinal obstruction;
* Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture according to the judgment of the investigator);
* Clinically significant electrolyte abnormalities judged by researchers;
* With active bleeding or obvious evidence of bleeding tendency;
* Hypertension that cannot be controlled by drugs: systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 100 mmHg;
* Women who are pregnant or lactating;
* Urinary protein ≥ ++, or the 24-hour urine protein quantification is greater than 1.0g;
* Concurrent tumors within 5 years (except treated cervical carcinoma in situ, basal cell carcinoma);
* Any disease or state that affects the absorption of drugs, or the subject cannot take oral drugs;
* Known human immunodeficiency virus (HIV) infection;
* History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×10\^4/ml or \>2000 IU/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×10\^3/m); hepatitis and cirrhosis;
* Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not suitable for enrolling according to the judgment of the investigator.

Where it's running

• Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Jihui Hao, M.D. — Tianjin Medical University Cancer Institute and Hospital
• Study coordinator: Jihui Hao, M.D.
• Email: ec_tjcih@126.com
• Phone: 022-23524155

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.