- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05024812
Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
August 17, 2022 updated by: Feng Wang, The First Affiliated Hospital of Zhengzhou University
An Open Label, Single Arm, Multicenter Phase Ⅰb/Ⅱ Clinical Study of Fruquintinib Combined With Toripalimab and SOX Regimen in the First-line Treatment of Advanced Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
This is a prospective, open-label, multicenter, single arm phase Ⅰb/Ⅱ clinical study aims to explore the efficacy and safety of fruquintinib combined with toripalimab and SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
At present, the first-line standard treatment of metastatic gastric cancer is still doublet or triplet chemotherapy of fluorouracil combined with platinum or paclitaxel.
In recent years, immune checkpoint inhibitors (ICIs) have emerged in advanced gastric cancer with their unique mechanism of action.
PD-1 monoclonal antibody has been explored in multiple combination schemes in the first-line treatment of advanced gastric cancer.
This study aims to explore the efficacy and safety of an antiangiogenetic TKI, fruquintinib combined with an ICI, toripalimab and the standard doublet SOX regimen in the first-line treatment of unresectable advanced metastatic gastric or gastroesophageal junction adenocarcinoma.
Study Type
Interventional
Enrollment (Anticipated)
64
Phase
- Phase 2
- Phase 1
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: Feng Wang, M.D.
- Phone Number: 860013938244776
- Email: fengw010@163.com
Study Contact Backup
- Name: Qingxia Fan, M.D.
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Qingxia Fan, doctor
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathologically determined unresectable advanced gastric or gastroesophageal junction adenocarcinoma;
- 18-75 years old (including 18 and 75 years old);
- No previous anti-tumor treatment for metastatic diseases;
- HER2 negative;
- Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;
- Life expectancy ≥ 3 months;
- At least one measurable lesion according to RECIST version 1.1;
- Adequate organ and bone marrow functions:
Absolute neutrophil count≥1.5x10^9/L; Platelet count≥100x10^9/L; Hemoglobin≥9g/dL; Serum bilirubin≤1.5x the upper limit of normal(ULN); Alanine aminotransferase(ALT) and aspartate aminotransferase(AST)≤1.5x ULN; Serum creatinine≤1.5x ULN; Endogenous creatinine clearance rate ≥ 50ml / min;
- Women of childbearing age need to take effective contraceptive measures.
Exclusion Criteria:
- Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or previous use of immune checkpoint inhibitors;
- Other malignant tumors in the past 5 years, except for skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
- There was central nervous system (CNS) metastasis or previous brain metastasis before enrollment;
- Patients with autoimmune diseases or history of autoimmune diseases within 4 weeks before enrollment;
- Previously received allogeneic bone marrow transplantation or organ transplantation;
- Uncontrolled malignant ascites;
- Participated in other unapproved or unlisted drug clinical trials in China within 4 weeks before enrollment, and received corresponding experimental drug treatment;
- Cardiovascular disease, including unstable angina or myocardial infarction, occurred within 6 months before the start of study treatment;
- Subjects allergic to the study drug or any of its adjuvants;
- International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
- The researchers judged clinically significant electrolyte abnormalities;
- At present, the patient has hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
- Patients currently have poorly controlled diabetes (fasting glucose level is greater than CTCAE grade 2 after regular treatment);
- Patients with dysphagia, active peptic ulcer, intestinal obstruction, active gastrointestinal bleeding, peptic perforation, malabsorption syndrome or uncontrolled intestinal inflammatory diseases;
- Any disease or state affecting drug absorption before enrollment, or the patient cannot take oral medication;
- Patients with obvious evidence of bleeding tendency or medical history within 3 months before enrollment, hemoptysis or thromboembolism within 12 months;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment;
- Ventricular arrhythmia requiring drug treatment;
- Congestive heart failure ≤New York Heart Association (NYHA) class 2;
- LVEF < 50%;
- Active or uncontrolled severe infection ≥ grade 2 according to National Cancer Institute Common Toxicity (NCI-CTC) criteria;
- With positive urine protein and 24-hour urinary protein content>1g;
- Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis;
- Pregnant (positive pregnancy test before medication) or lactating women;
- Complications require long-term immunosuppressive treatment, or systemic or local use of immunosuppressive corticosteroids (> 10mg / day prednisone or other therapeutic hormones);
- By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.
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: Experimental
fruquintinib + toripalimab + SOX
|
phase Ib: fruquintinib (dose finding): L1: 3 mg/d,L2: 4 mg/d,L3: 5 mg/d, qd po, D1-14, Q3W toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W.
phase II: fruquintinib: RP2D toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLTs
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
DLTs are defined as grade 3 or higher adverse events that are related to fruquintinib during the first cycle of therapy.
|
At the end of Cycle 1 (each cycle is 28 days)
|
RP2D
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D)
|
At the end of Cycle 1 (each cycle is 28 days)
|
PFS
Time Frame: about 2 years
|
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
|
about 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
OS
Time Frame: about 2 years
|
The time from treatment initiation until death from any reason
|
about 2 years
|
ORR
Time Frame: about 2 years
|
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart
|
about 2 years
|
DCR
Time Frame: about 2 years
|
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)
|
about 2 years
|
DoR
Time Frame: about 2 years
|
Duration of Response is defined as the time from the first documentation of response (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders
|
about 2 years
|
adverse events (AEs) categorized by severity in accordance with the NCI CTC AE Version 5.0
Time Frame: about 2 years
|
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
|
about 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
June 1, 2022
Primary Completion (Anticipated)
August 1, 2023
Study Completion (Anticipated)
February 1, 2025
Study Registration Dates
First Submitted
August 20, 2021
First Submitted That Met QC Criteria
August 25, 2021
First Posted (Actual)
August 27, 2021
Study Record Updates
Last Update Posted (Actual)
August 18, 2022
Last Update Submitted That Met QC Criteria
August 17, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMPL-013-FLAG-G102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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