- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05481476
Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer
August 8, 2023 updated by: Dong sheng Zhang, Sun Yat-sen University
A Single-center, Single-arm, Phase II Clinical Study of 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Phase 2
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
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Recruiting
- Cancer center of SunYat-sen University
-
Contact:
- Dongsheng Zhang, MD,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.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Informed consent has been signed
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer
- Age ≥ 18 years, ≤75 years, male or female
- ECOG PS:0-1, expected overall survival ≥12 months
- Patients who have not previously received systemic therapy for locally advanced or metastatic pancreatic cancer
- 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
- Patients must have at least one measurable liver metastases (RECIST 1.1)
- No serious organic diseases of the heart, lungs, brain and other organs
- Patients must have adequate organ and bone marrow function
- 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:
- Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment
- Previously received VEGFR inhibitors or immune checkpoint inhibitors
- Patients with BRCA1/2 germline mutations
- Patients with obstructive jaundice but less than expected jaundice
- Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ
- Patients previously had brain metastasis or current brain metastasis
- Investigator determines that the liver metastases account for 70% or more of the total liver volume
- 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
- Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases within 4 weeks before enrollment
- Clinically significant electrolyte abnormality
- Patient currently has uncontrolled hypertension, defined as: systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg
- Proteinuria ≥ 2+ (1.0g/24hr)
- 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
- Have evidence or history of bleeding tendency within 3 months, Significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment
- 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
- Active or uncontrolled serious infection (≥CTCAE grade 2 infection)
- Unrelieved toxic reactions ≥ CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of ≤ grade 2 caused by oxaliplatin
- Pregnant or lactating women
- 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
- 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])
- 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.)
- Patients who are allergic or suspected to be allergic to the study drug or similar drugs
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: surufatinib combined with sintilimab and AG
|
250mg, qd, po, 21 days for a cycle
200mg, ivgtt, d1, 21 days for a cycle, up to 2 years
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate (ORR)
Time Frame: up to 24 months
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-Free Survival (PFS)
Time Frame: up to 24 months
|
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 investigator
|
up to 24 months
|
disease control rate (DCR)
Time Frame: up to 24 months
|
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 investigator
|
up to 24 months
|
overall survival (OS)
Time Frame: up to 24 months
|
OS is the time from enrollment to death due to any cause.
|
up to 24 months
|
adverse events (AE)
Time Frame: up to 24 months
|
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
|
Molecular markers and imaging parameters predicting therapeutic efficacy
Time Frame: up to 24 months
|
Peripheral 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 elastography
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Estimated)
September 1, 2023
Primary Completion (Estimated)
August 1, 2024
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
July 28, 2022
First Submitted That Met QC Criteria
July 28, 2022
First Posted (Actual)
August 1, 2022
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 8, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMPL-012-SPRING-P103
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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