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

RenJi Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stomach Neoplasms

Interventions

FruquintinibDRUG

Fruquintinib: 5mg po, d1-d14, q3w

SintilimabDRUG

Sintilimab: 200mg ivgtt, d1, q3w

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Renji Hospital

Shanghai, China

Outcomes

Primary Outcomes

Objective response rate (ORR)

The proportion of patients with complete response or partial response, using RECIST v 1.1.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 12 months

Overall survival (OS)

Time from randomization to death from any cause.

Time frame: 12 months

Disease Control Rate (DCR)

The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.

Time frame: 12 months

Adverse Events

Adverse event assessed according to CTCAE v5.0.

Time frame: 12 months

Data from ClinicalTrials.gov

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