A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• Fully understand the study and voluntarily sign the informed consent form;

• Age between 18 and 75 years;

• Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;

• Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;

• R0 resection after neoadjuvant chemotherapy;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

• Life expectancy of at least 2 years;

• No prior anti-cancer treatment received;

• Good compliance and cooperation with follow-up.

Locations
Other Locations
China
Henan Cancer Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Fei Ma, M.D.
mafeizzu@outlook.com
+8613703923592
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 69
Treatments
Experimental: Experimental group
Fruquintinib Combined with Standard Chemotherapy
Related Therapeutic Areas
Sponsors
Leads: Henan Cancer Hospital

This content was sourced from clinicaltrials.gov