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

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

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 Overview

• Status: Active, not recruiting
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Drug: Fruquintinib; Drug: Sintilimab

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200000
    • RenJi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fruquintinib+Sintilimab; Fruquintinib: 5mg po, d1-d14, q3w Sintilimab: 200mg ivgtt, d1, q3w	Drug: Fruquintinib; Fruquintinib: 5mg po, d1-d14, q3w; Drug: Sintilimab; Sintilimab: 200mg ivgtt, d1, q3w

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Shuiping Tu, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: March 31, 2023
• First Posted (Actual): April 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 27, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: HMPL-013-SH-GC-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No