Status:
NOT_YET_RECRUITING
Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Locally Advanced Pancreatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and...
Detailed Description
A total of 50 participants are expected to be enrolled in this study; 25 will receive the surufatinib and serplulimab in conjunction with albumin-paclitaxel and gemcitabine regimen and 25 will receive...
Eligibility Criteria
Inclusion
- Written informed consent obtained from the patient prior to treatment.
- Pathologically confirmed unresectable locally advanced pancreatic cancer, received no surgical therapy.
- Age between 18 and 75 years at the time of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Measurable or evaluable lesions according to RECIST v1.1 criteria.
- Life expectancy ≥ 12 weeks.
- There are no serious organic diseases of the heart, lungs, brain and other organs.
- Adequate functioning of the bone marrow and major organs function meeting the following criteria:
- White blood cell count ≥ 4 × 109/L, Neutrophil count ≥ 1.5 × 109/L, Platelets count ≥ 100 × 109/L,Hemoglobin ≥ 90 g/L.
- Normal coagulation function, without active bleeding or thrombotic diseases: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
- Liver function: Total serum bilirubin ≤ 1.5 ×ULN, Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 × ULN, Obstructive Jaundice with total serum bilirub ≤ 1.5 x ULN after internal/ external drainage.
- Kidney function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min.
- Cardiac function:left ventricular ejection fraction (LVEF) of 50%≥ on 2D cardiac ultrasound.
- Male or female patients of potential for childbearing who voluntarily used effective contraceptive methods such as double-barrier contraception, condoms, oral or injection avoidance or pregnancy medications, IUDs, etc during the study period and within 6 months of the last study medication . All female patients will be considered fertile unless the female patient is naturally menopausal.
Exclusion
- Participants diagnosed pancreatic cancer with distant metastases.
- Participation in other antineoplastic drug clinical trials within 4 weeks prior to enrollment;
- Previous systemic antitumor therapy (chemotherapy, radiation, targeted or immunoth, etc.).
- Diagnosis of any second malignancy, except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix uteri.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants are being treated with immunosuppressants, or systemic or absorbable topical hormones for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent hormones) , and the use is still continued within 2 weeks before enrollment.
- Have undergone any surgery (other than biopsy) or invasive treatment or manipulation within 4 weeks prior to enrollment and the surgical incision has not healed completely (except intravenous catheterization, puncture drainage, internal or external drainage of obstructive jaundice, etc.)
- Participants with abnormal thyroid function who were unable to maintain thyroid function within the normal range with medical treatment.
- Hypertension that cannot be controlled in the presence of optimal treatment is defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
- Urinary routine showed that urinary protein ≥2+, and 24-hour urinary protein\>1.0g.
- Participantst currently has any disease or condition that affects the absorption of the drug, or the participants cannot take sulfatinib orally
- participants with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding\>30 mL within 3 months with hematemesis, melena, hematochezia), hemoptysis (fresh blood\>5 mL within 4 weeks); Patients with history of hereditary or acquired bleeding or coagulation dysfunction, with clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding and hemorrhagic gastric ulcer.
- Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) grade \> 2 for congestive heart failure; ventricular arrhythmias requiring drug therapy; Electrocardiogram (ECG) showing QT interval ≥480 ms;
- Severe infection that is active or uncontrolled:
- Inherited or acquired immunodeficiency disease,
- Known clinically significant history of liver disease, including viral hepatitis \[known hepatitis B virus (HBV) carriers must exclude active HBV infection , HBV DNA positive (\>1×104 copies/mL or \>2000 IU/ml)\];
- known hepatitis C virus infection (HCV) and positive HCV RNA (\>1×103 copies/ml) or other hepatitis, cirrhosis.
- Pregnant or lactating women or participants with family planning during the trial period.
- Participants have a known history of psychotropic substance abuse, alcoholism, or drug abuse.
- The investigator believes that the participant has any clinical or laboratory abnormalities or other reasons that are unsuitable for this clinical study.
Key Trial Info
Start Date :
October 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 23 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05988372
Start Date
October 23 2023
End Date
October 23 2026
Last Update
November 1 2023
Active Locations (1)
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1
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080