NCT07436741 Surufatinib Plus Gemcitabine and Nab-paclitaxel vs. Gemcitabine Plus Nab-paclitaxel in Neoadjuvant Therapy for High - Risk Resectable or Borderline Resectable Pancreatic Cancer
| NCT ID | NCT07436741 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Pancreatic Cancer, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2026-03-03 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 106 participants in total. It began in 2026-03-03 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To explore the efficacy and safety of surufatinib in combination with AG regimen verus AG regimen as peri-operative treatment in high - risk resectable or borderline resectable pancreatic cancer
Eligibility Criteria
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.
Contact & Investigator
Jihui Hao, M.D.
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT07436741 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Pancreatic Cancer, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07436741 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 106 participants.
Is NCT07436741 currently recruiting?
Yes, NCT07436741 is actively recruiting participants. Contact the research team at ec_tjcih@126.com for enrollment information.
Where is the NCT07436741 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07436741 clinical trial?
NCT07436741 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Jihui Hao, M.D. at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 106 participants.
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