Fruquintinib and SOX for treating advanced gastric cancer before surgery

A Single-arm, Multicenter, Open-label Phase II Study of Fruquintinib Plus SOX as a Neoadjuvant Therapy for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

This study is testing a new combination treatment with Fruquintinib and SOX for patients with advanced stomach cancer to see if it helps shrink the tumor before surgery and improves their chances of recovery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Guangxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Fruquintinib
• Locations: 1 site (Nanning)
• Trial ID: NCT05122091 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination therapy using Fruquintinib and SOX as neoadjuvant treatment for patients with locally advanced gastric or gastroesophageal junction adenocarcinoma. The aim is to downstage the cancer, improve the rate of complete surgical resection, and reduce the chances of recurrence and metastasis. This single-arm, multicenter, open-label phase II study will include patients who have not received prior antitumor therapies and will assess both the efficacy and safety of the treatment approach.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with pathologically confirmed resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.

Not a fit: Patients with prior antitumor therapies or those with distant metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve surgical outcomes and long-term survival rates for patients with advanced gastric cancer.

How similar studies have performed: While the combination of Fruquintinib and SOX is a novel approach, similar neoadjuvant therapies have shown promise in improving outcomes for gastric cancer patients.

Eligibility criteria

Inclusion Criteria:

1. Ages: 18-75 Years（concluding 18 and 75 Years）;
2. Pathologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0) ;
3. Bone scan should be performed if bone metastasis is suspected. If peritoneal metastasis is suspected, abdominal examination should be performed to exclude distant metastasis；
4. ECOG PS 0-1, there was no deterioration within 7 days;
5. BMI≥18；
6. Has life expectancy of greater than 12 months；
7. No prior antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.)；
8. Have measurable lesions (according to RECIST 1.1);
9. The main organ functions meet the following criteria: (without blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment):

   1. Absolute Neutrophil Count (ANC)≥1.5×109/L, White Blood Cell≥4.0×109/L；
   2. Platelet Count of ≥100×109/L；
   3. Hemoglobin≥90g/L；
   4. Total Bilirubin (TBIL)≤1.5 x ULN；
   5. ALT and AST≤2.5 x ULN；
   6. Urea/Urea Nitrogen（BUN）and Creatinine（Cr）≤1.5×ULN (and creatinine clearance (CCr)≥ 50mL/min);
   7. Left Ventricular Ejection Fraction (LVEF)≥50%;
   8. Electrocardiogram (ECG) Corrected QT Interval (QTcF)\<470ms;
   9. INR≤1.5×ULN，APTT≤1.5×ULN;

Exclusion Criteria:

1. Received anti-VEGF/VEGFR-targeted drugs and progressed upon these drugs;
2. HER 2+;
3. Live vaccines were administered within 4 weeks prior to enrollment or possibly during the study period;
4. A history of other malignancies within 5 years prior to inclusion, except for cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery;
5. Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment;
6. Previously received allogeneic stem cell or parenchymal organ transplantation;
7. Previously with serious cardiovascular disease, including unstable angina or myocardial infarction within 6 months prior to enrollment;
8. Known hypersensitivity to any of the study drugs or excipients;
9. Distant metastasis to any part of the body；
10. Have received other investigational treatments in clinical studies within 4 weeks prior to enrollment;
11. Any significant clinical or laboratory abnormality that the investigator considers to influence the safety evaluators;
12. Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg；
13. With any diseases or conditions prior to enrollment that affected drug absorption, or patients could not take drugs orally;
14. Have a gastrointestinal disease or condition that investigators suspect may affect drug absorption, including, but not limited to, active gastric and duodenal ulcers, ulcerative colitis and other digestive disease, gastrointestinal tumor with active bleeding, or other gastrointestinal conditions that may cause bleeding or perforation, according to the investigator's judgement;
15. History or presence of a serious hemorrhage (\>30 ml within 3 months), hemoptysis (\>5 ml blood within 4 weeks) or life threatening thromboembolic event within 12 months;
16. Have clinically significant cardiovascular disease, including but not limited to, acute myocardial infarction; severe/unstable angina pectoris or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure according to the New York Heart Association (NYHA) classification ≥ 2; ventricular 26 arrhythmias which needs drug treatment; or left ventricular ejection fraction (LVEF) \<50%;
17. Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;
18. History of clinically significant hepatic disease, including, but not limited to, known hepatitis B virus (HBV) infection with HBV DNA positive (copies ≥1×104/ml); known hepatitis C virus infection with HCV RNA positive (copies ≥1×103/m); or liver cirrhosis, etc;
19. Adverse events (AEs) due to previous anti-tumor therapy has not recovered to Common Terminology Criteria for Adverse Event (CTCAE) ≤Grade 1. Alopecia, lymphocytopenia, and grade 2 neurotoxicity due to oxaliplatin are not included;
20. Women who are pregnant or lactating;
21. With blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment;
22. Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions which, according to judgement of the investigator, renders the patient inappropriate for using the investigational product or affect interpretation of study results;
23. Urine routine indicates urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g;
24. Patients considered unsuitable for inclusion in this study by the investigator.

Where this trial is running

Nanning

• Guangxi Medical University Cancer Hospital — Nanning, China (Recruiting)

Study contacts

• Study coordinator: Yuzhou Qin

Conditions Gastric Cancer; GastroEsophageal Cancer; Fruquintinib; SOX; Gastric cancer; Neoadjuvant