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

Primary Purpose

Pancreatic Neoplasms

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Surufatinib
Sintilimab
AG
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cancer center of SunYat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

surufatinib combined with sintilimab and AG

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 investigator
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 investigator
overall survival (OS)
OS is the time from enrollment to death due to any cause.
Molecular markers and imaging parameters predicting therapeutic efficacy
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
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.

Full Information

First Posted
July 28, 2022
Last Updated
August 8, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05481476
Brief Title
Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surufatinib combined with sintilimab and AG
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Surufatinib
Intervention Description
250mg, qd, po, 21 days for a cycle
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
200mg, ivgtt, d1, 21 days for a cycle, up to 2 years
Intervention Type
Drug
Intervention Name(s)
AG
Intervention 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
Primary Outcome Measure Information:
Title
objective response rate (ORR)
Description
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
Time Frame
up to 24 months
Title
disease control rate (DCR)
Description
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
Time Frame
up to 24 months
Title
overall survival (OS)
Description
OS is the time from enrollment to death due to any cause.
Time Frame
up to 24 months
Title
Molecular markers and imaging parameters predicting therapeutic efficacy
Description
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
Time Frame
up to 24 months
Title
adverse events (AE)
Description
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.
Time Frame
up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dongsheng Zhang, PhD
Phone
86-2087343795
Email
zhangdsh@sysucc.org.cn
Facility Information:
Facility Name
Cancer center of SunYat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongsheng Zhang, MD,PhD
Phone
86-2087343795
Email
zhangdsh@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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