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Clinical Trial Record

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Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

2023-09

2024-08

2025-08

32

Study Overview

Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

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.

N/A

  • Pancreatic Neoplasms
  • DRUG: Surufatinib
  • DRUG: Sintilimab
  • DRUG: AG
  • HMPL-012-SPRING-P103

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-07-28  

N/A  

2023-08-08  

2022-07-28  

N/A  

2023-08-09  

2022-08-01  

N/A  

2023-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: surufatinib combined with sintilimab and AG

DRUG: Surufatinib

  • 250mg, qd, po, 21 days for a cycle

DRUG: Sintilimab

  • 200mg, ivgtt, d1, 21 days for a cycle, up to 2 years

DRUG: AG

  • 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
Primary Outcome MeasuresMeasure DescriptionTime Frame
objective response rate (ORR)Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.up to 24 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Progression-Free Survival (PFS)PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigatorup to 24 months
disease control rate (DCR)DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigatorup to 24 months
overall survival (OS)OS is the time from enrollment to death due to any cause.up to 24 months
Molecular markers and imaging parameters predicting therapeutic efficacyPeripheral blood was collected from patients during the screening period, treatment period and safety follow-up period, and serum pathological examinations were performed; tumor imaging evaluation added elastographyup to 24 months
adverse events (AE)overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.up to 24 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dongsheng Zhang, PhD

Phone Number: 86-2087343795

Email: zhangdsh@sysucc.org.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.

The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.

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