Pancreatic Cancer, Adult
Conditions
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
Interventions
Neoadjuvant therapy: Surufatinib: 250mg, QD po; Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
Neoadjuvant therapy: Nab-paclitaxel: 125mg/m2, I.V., D1/8, Q3W; Gemcitabine: 1000/m2,I.V., D1/8, Q3W. Adjuvant therapy: Gemcitabine: 1000/m2,I.V., D1/8, Q3W; Capecitabine: 1650-2000mg/(m2·d) bid, po, d1-14, Q3W.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complete resection rate (R0) | about 1 year | This is a complete macroscopic resection of the gross tumor with negative surgical margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | about 2 years | The time from randomization to the first event of disease progression that precluded surgery, local or distant recurrence, or death from any cause |
| Objective Response Rate (ORR) | about 1 year | ORR= Complete response rate + partial response rate |
| Disease Control Rate (DCR) | about 1 year | DCR= Complete response rate + partial response rate + disease stable rate |
| Downstaging Rate | about 1 year | To determine the rate of downstaging after preoperative therapy |
| Pathological complete response (pCR) rate | about 1 year | pCR is defined as the absence of residual tumor cells in the pathological examination after resection |
| Overall survival (OS) | about 5 years | Time from randomization to death |
| Adverse events (AEs) | about 2 years | treatment-related adverse events and serious adverse events as assessed by CTCAE v6.0 |
Countries
China
Contacts
CONTACTJihui Hao, M.D.
CONTACTSong Gao, M.D.
PRINCIPAL_INVESTIGATORJihui Hao, M.D.
Tianjin Medical University Cancer Institute and Hospital
PRINCIPAL_INVESTIGATORSong Gao, M.D.
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed