Combining Fruquintinib with chemotherapy for treating gastric cancer after surgery

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.

This study is testing if adding Fruquintinib to standard chemotherapy can help people with HER2-negative gastric cancer who had surgery and are at high risk of their cancer coming back.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: chemotherapy, Fruquintinib
• Locations: 1 site (Zhengzhou)
• Trial ID: NCT06774222 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Fruquintinib in combination with standard chemotherapy as an adjuvant treatment for patients with HER2-negative gastric cancer who have a poor tumor regression grade (TRG) following surgery. The primary goal is to evaluate the recurrence-free survival (RFS) of these patients after receiving this combined therapy. Secondary objectives include assessing overall survival (OS) and the safety profile of the treatment. The study aims to provide a new therapeutic approach to improve outcomes for patients who are at high risk of tumor recurrence.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable locally advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma and poor TRG after neoadjuvant chemotherapy.

Not a fit: Patients with HER2-positive gastric cancer or those with distant metastasis will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with poor TRG after surgery for gastric cancer.

How similar studies have performed: While the combination of Fruquintinib with chemotherapy is a novel approach, similar studies have shown promise in improving outcomes for patients with advanced gastric cancer.

Eligibility criteria

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.

Where this trial is running

Zhengzhou

• Henan Cancer Hospital — Zhengzhou, China (Recruiting)

Study contacts

• Principal investigator: Fei Ma, M.D. — Working relationship
• Study coordinator: Fei Ma, M.D.

Conditions Gastric/Gastroesophageal Junction Adenocarcinoma