A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG

NCT06774222 | Recruiting Phase 2

• 1 other identifier: 2022-421
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric/Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year recurrence-free survival rate

  Percentage of recurrence-free patients within 3 years of surgery

  Three years after surgery

Secondary Outcomes (2)

• Overall survival

  OS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years"

• AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  from the first drug administration to within 30 days for the last dose

Study Arms (1)

Experimental group

EXPERIMENTAL

Fruquintinib Combined with Standard Chemotherapy

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks

Also known as: HMPL-013

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to comply with the study protocol or procedures;
• History of prior gastric cancer surgery;
• Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
• Distant metastasis to organs other than the liver, such as lung, brain, and bone;
• Known HER2-positive patients;
• Uncontrolled hypertension despite medication prior to enrollment;
• Poorly controlled diabetes despite medication prior to enrollment;
• Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g;
• Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
• Patients deemed ineligible for this study by the investigator.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

HMPL-013

Study Officials

• Fei Ma, M.D.

  Working relationship

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Ma, M.D.

CONTACT

+8613703923592; mafeizzu@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 14, 2025
• Study Start: September 12, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2025

Record last verified: 2024-11

Locations

CN (1)