Stomach Neoplasms
Conditions
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.
Interventions
DRUGFruquintinib
Fruquintinib: 5mg po, d1-d14, q3w
DRUGSintilimab
Sintilimab: 200mg ivgtt, d1, q3w
Sponsors
RenJi Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 12 months | The proportion of patients with complete response or partial response, using RECIST v 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Disease Control Rate (DCR) | 12 months | The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1. |
| Adverse Events | 12 months | Adverse event assessed according to CTCAE v5.0. |
Countries
China
Outcome results
None listed