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

Who is this study for? Patients with locally advanced gastric or gastroesophageal junction adenocarcinoma
What treatments are being studied? Fruquintinib+SOX
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

For locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0 ), neoadjuvant therapy can downstage T and N stage, improve R0 resection rate, reduce recurrence and metastasis rates, and finally improve the long-term survival. A combination of Fruquintinib and SOX for locally advanced gastric/gastroesophageal junction adenocarcinoma could be a novel therapy. This study intends to evaluate the efficacy of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ages: 18-75 Years(concluding 18 and 75 Years);

• Pathologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma (cT3/4aN+M0) ;

• Bone scan should be performed if bone metastasis is suspected. If peritoneal metastasis is suspected, abdominal examination should be performed to exclude distant metastasis;

• ECOG PS 0-1, there was no deterioration within 7 days;

• BMI≥18;

• Has life expectancy of greater than 12 months;

• No prior antitumor therapy (e.g., radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.);

• Have measurable lesions (according to RECIST 1.1);

• 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):

‣ Absolute Neutrophil Count (ANC)≥1.5×109/L, White Blood Cell≥4.0×109/L;

⁃ Platelet Count of ≥100×109/L;

⁃ Hemoglobin≥90g/L;

⁃ Total Bilirubin (TBIL)≤1.5 x ULN;

⁃ ALT and AST≤2.5 x ULN;

⁃ Urea/Urea Nitrogen(BUN)and Creatinine(Cr)≤1.5×ULN (and creatinine clearance (CCr)≥ 50mL/min);

⁃ Left Ventricular Ejection Fraction (LVEF)≥50%;

⁃ Electrocardiogram (ECG) Corrected QT Interval (QTcF)\<470ms;

⁃ INR≤1.5×ULN,APTT≤1.5×ULN;

Locations
Other Locations
China
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Contact Information
Primary
Yuzhou Qin
qyz402@126.com
+867715310421
Backup
Liucheng Wu
Time Frame
Start Date: 2021-11-05
Estimated Completion Date: 2024-11-30
Participants
Target number of participants: 53
Treatments
Experimental: Fruquintinib group
Two-four preoperative cycles of Fruquintinib plus SOX. One cycle consists of Day 1-14 Fruquintinib 5mg oral (daily), Day 1 Oxaliplatin 130mg/M2 intravenous, Day 1-14 Tegafur gimeracil oteracil potassium capsule 40-60mg bid(dosage according to body surface area).~Repeated every 21st day
Related Therapeutic Areas
Sponsors
Leads: Guangxi Medical University

This content was sourced from clinicaltrials.gov