Efficacy and Safety of Fruquintinib With Sintilimab as First-line Therapy in Gastric Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Study of Fruquintinib in Combination With Sintilimab as a First-line Therapy in Gastric Adenocarcinoma/Adenocarcinoma of Esophagogastric Junction

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Drug: Fruquintinib
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fruquintinib+Sintilimab<br>Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w | Drug: Fruquintinib<br>* Fruquintinib: 5mg po, d1-d14, q3w<br>Drug: Sintilimab<br>* Sintilimab: 200mg ivgtt, d1, q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The proportion of patients with complete response or partial response, using RECIST v 1.1. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 months | 
| Overall survival (OS) | Time from randomization to death from any cause. | 12 months | 
| Disease Control Rate (DCR) | The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1. | 12 months | 
| Adverse Events | Adverse event assessed according to CTCAE v5.0. | 12 months |