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

Phase 2RecruitingNCT06774222

Henan Cancer Hospital69 enrolled

Overview

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. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric/Gastroesophageal Junction Adenocarcinoma

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Fully understand the study and voluntarily sign the informed consent form; 2. Age between 18 and 75 years; 3. Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma; 4. Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy; 5. R0 resection after neoadjuvant chemotherapy; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 7. Life expectancy of at least 2 years; 8. No prior anti-cancer treatment received; 9. Good compliance and cooperation with follow-up. Exclusion Criteria: 1. Inability to comply with the study protocol or procedures; 2. History of prior gastric cancer surgery; 3. Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery; 4. Distant metastasis to organs other than the liver, such as lung, brain, and bone; 5. Known HER2-positive patients; 6. Uncontrolled hypertension despite medication prior to enrollment; 7. Poorly controlled diabetes despite medication prior to enrollment; 8. Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification \>1.0g; 9. Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment; 10. Patients deemed ineligible for this study by the investigator.

Outcomes

Primary Outcomes

3-year recurrence-free survival rate

Percentage of recurrence-free patients within 3 years of surgery

Time frame: Three years after surgery

Secondary Outcomes

Overall survival

From the start of treatment to the date of death from any cause

Time frame: 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

Patients' blood and non-blood abnormal values or conditions were collected according to the frequency of visits per cycle and recorded for evaluation using CTCAE5.0 criteria

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