Back to resultsEfficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
Primary Purpose
Stomach Neoplasms
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fruquintinib
Sintilimab
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasms
Eligibility Criteria
Inclusion Criteria: Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction; ECOG PS: 0-2; Adequate hepatic, renal, heart, and hematologic functions; At least one measurable lesion (according to RECIST1.1); Haven't received any systematic treatment for the cancer involved; Expected survival > 12 weeks; Contraception until 6 months after the study termination; Signed informed consent. Exclusion Criteria: Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor; Participated in another study; Immunodeficiency; Received allograft； Unmanageable hypertension, diabetes, or coronary disease; Have difficulty in taking medicine, or active bleeding; Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy; Infection of HIV, HBV, HCV, or other unmanageable infection; Other malignant tumor history; Allergic to the test drug; Other diseases which will affect the results of this study; Received resection of stomach; Taking anti-tumor traditional Chinese Medicine; Severe active bleeding.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fruquintinib+Sintilimab
Arm Description
Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
The proportion of patients with complete response or partial response, using RECIST v 1.1.
Secondary Outcome Measures
Progression-Free Survival (PFS)
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
Overall survival (OS)
Time from randomization to death from any cause.
Disease Control Rate (DCR)
The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Adverse Events
Adverse event assessed according to CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05795296
Brief Title
Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
Official Title
Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
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
The goal of this clinical trial is to explore the efficacy and safety in patients with gastric adenocarcinoma or adenocarcinoma of esophagogastric junction. The main questions it aims to answer are:
Does this therapy have a promising efficacy?
Does this therapy have a manageable toxicity? Participants will receive fruquintinib plus sintilimab as first-line therapy for gastric cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach 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
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fruquintinib+Sintilimab
Arm Type
Experimental
Arm Description
Fruquintinib: 5mg po, d1-d14, q3w
Sintilimab: 200mg ivgtt, d1, q3w
Intervention Type
Drug
Intervention Name(s)
Fruquintinib
Intervention Description
Fruquintinib: 5mg po, d1-d14, q3w
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
Sintilimab: 200mg ivgtt, d1, q3w
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The proportion of patients with complete response or partial response, using RECIST v 1.1.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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
12 months
Title
Overall survival (OS)
Description
Time from randomization to death from any cause.
Time Frame
12 months
Title
Disease Control Rate (DCR)
Description
The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Time Frame
12 months
Title
Adverse Events
Description
Adverse event assessed according to CTCAE v5.0.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histological or cytological confirmed advanced, recurrent, of metastatic gastric adenocarcinoma or adenocarcinoma of esophagogastric junction;
ECOG PS: 0-2;
Adequate hepatic, renal, heart, and hematologic functions;
At least one measurable lesion (according to RECIST1.1);
Haven't received any systematic treatment for the cancer involved;
Expected survival > 12 weeks;
Contraception until 6 months after the study termination;
Signed informed consent.
Exclusion Criteria:
Her-2-positive gastric cancer, or exposed to any immune checkpoint inhibitor;
Participated in another study;
Immunodeficiency;
Received allograft；
Unmanageable hypertension, diabetes, or coronary disease;
Have difficulty in taking medicine, or active bleeding;
Pulmonary tuberculosis, or interstitial lung disease that needs steroid therapy;
Infection of HIV, HBV, HCV, or other unmanageable infection;
Other malignant tumor history;
Allergic to the test drug;
Other diseases which will affect the results of this study;
Received resection of stomach;
Taking anti-tumor traditional Chinese Medicine;
Severe active bleeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuiping Tu
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.
Learn more about this trial
Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
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