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

Shanghai Jiao Tong University

Status and phase

Active, not recruiting

Phase 2

Conditions

Stomach Neoplasms

Treatments

Drug: Sintilimab

Drug: Fruquintinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05795296

HMPL-013-SH-GC-101

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.