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Trial Title:
Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
NCT ID:
NCT05795296
Condition:
Stomach Neoplasms
Conditions: Official terms:
Stomach Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib
Description:
Fruquintinib: 5mg po, d1-d14, q3w
Arm group label:
Fruquintinib+Sintilimab
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab: 200mg ivgtt, d1, q3w
Arm group label:
Fruquintinib+Sintilimab
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Start date:
December 1, 2022
Completion date:
August 31, 2025
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05795296
