Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer
- Conditions
- Stomach Neoplasms
- Interventions
- Registration Number
- NCT05795296
- Lead Sponsor
- RenJi Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fruquintinib+Sintilimab Fruquintinib Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w Fruquintinib+Sintilimab Sintilimab Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) 12 months The proportion of patients with complete response or partial response, using RECIST v 1.1.
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) 12 months The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.
Progression-Free Survival (PFS) 12 months 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) 12 months Time from randomization to death from any cause.
Adverse Events 12 months Adverse event assessed according to CTCAE v5.0.
Trial Locations
- Locations (1)
Renji Hospital
🇨🇳Shanghai, China