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Trial Title:
Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT ID:
NCT05481476
Condition:
Pancreatic Neoplasms
Conditions: Official terms:
Pancreatic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
250mg, qd, po, 21 days for a cycle
Arm group label:
surufatinib combined with sintilimab and AG
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
200mg, ivgtt, d1, 21 days for a cycle, up to 2 years
Arm group label:
surufatinib combined with sintilimab and AG
Intervention type:
Drug
Intervention name:
AG
Description:
nab-paclitaxel (125mg/ m2, ivgtt, d1, 8), Gemcitabine (1000mg/ m2, intravenous infusion
over 30min, d1, 8), 21 days for a cycle, up to 6 cycles
Arm group label:
surufatinib combined with sintilimab and AG
Summary:
This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the
efficacy and safety of surufatinib combined with sintilimab and AG in first-line therapy
of patients with locally advanced or metastatic pancreatic cancer.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer center of SunYat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongsheng Zhang, MD,PhD
Phone:
86-2087343795
Email:
zhangdsh@sysucc.org.cn
Start date:
September 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05481476
