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

NCT ID: NCT05795296

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-08-31

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fruquintinib+Sintilimab

Fruquintinib: 5mg po, d1-d14, q3w

Sintilimab: 200mg ivgtt, d1, q3w

Group Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

Fruquintinib: 5mg po, d1-d14, q3w

Sintilimab

Intervention Type: DRUG

Sintilimab: 200mg ivgtt, d1, q3w

Interventions

Fruquintinib

Fruquintinib: 5mg po, d1-d14, q3w

Intervention Type: DRUG

Sintilimab

Sintilimab: 200mg ivgtt, d1, q3w

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yingchun Xu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shuiping Tu

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital

Shanghai, , China

Countries

China

Other Identifiers

HMPL-013-SH-GC-101

Identifier Type: -

Identifier Source: org_study_id