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

Stomach Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05795296
• Other study ID #: HMPL-013-SH-GC-101
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: December 1, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Fruquintinib
Fruquintinib: 5mg po, d1-d14, q3w
• Sintilimab
Sintilimab: 200mg ivgtt, d1, q3w

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	The proportion of patients with complete response or partial response, using RECIST v 1.1.	12 months
Secondary	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
Secondary	Overall survival (OS)	Time from randomization to death from any cause.	12 months
Secondary	Disease Control Rate (DCR)	The proportion of patients with complete response, partial response or stable disease, using RECIST v 1.1.	12 months
Secondary	Adverse Events	Adverse event assessed according to CTCAE v5.0.	12 months