Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma

NCT05122091 | Recruiting Phase 2 DMC

• 1 other identifier: FRUTINEOGA
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; GastroEsophageal Cancer; Fruquintinib; SOX

Keywords

Gastric cancer; Fruquintinib; Neoadjuvant; SOX

Outcome Measures

Primary Outcomes (1)

• Pathological remission rate (PRR)

  Rate of patients with \< 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline

  Approximately 2 years

Secondary Outcomes (5)

• Disease free survival (DFS)

  Approximately 2 years

• Overall Survival (OS)

  Approximately 2 years

• Objective response rate (ORR)

  Approximately 2 years

• Major pathological response rate (MPR)

  30 days

• R0 resection rate

  30 days

Study Arms (1)

Fruquintinib group

EXPERIMENTAL

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

Drug: Fruquintinib + SOX

Interventions

Fruquintinib + SOX DRUG

Fruquintinib：5mg qd for 2 weeks on and 1 week off, q3w； SOX: Tegafur gimeracil oteracil potassium capsule: 40-60mg bid（dosage according to body surface area），d1-14，q3w； Oxaliplatin：130mg/m2，intravenous (IV) ，d1，q3w.

Fruquintinib 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:

• 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);

You may not qualify if:

• Received anti-VEGF/VEGFR-targeted drugs and progressed upon these drugs;
• HER 2+;
• Live vaccines were administered within 4 weeks prior to enrollment or possibly during the study period;
• Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment;
• Previously received allogeneic stem cell or parenchymal organ transplantation;
• Previously with serious cardiovascular disease, including unstable angina or myocardial infarction within 6 months prior to enrollment;
• Known hypersensitivity to any of the study drugs or excipients;
• Distant metastasis to any part of the body；
• Have received other investigational treatments in clinical studies within 4 weeks prior to enrollment;
• Any significant clinical or laboratory abnormality that the investigator considers to influence the safety evaluators;
• Hypertension that is not controlled by the drug, and is defined as: SBP ≥150 mmHg and/or DBP ≥90 mmHg；
• With any diseases or conditions prior to enrollment that affected drug absorption, or patients could not take drugs orally;
• 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;
• 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;
• 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%;

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University Cancer Hospital

Nanning, China

RECRUITING

Related Publications (1)

• Wu L, Yan H, Qin Y, Huang M, Wang T, Jin Q, Wei W. Fruquintinib plus oxaliplatin combined with S-1 (SOX) as neoadjuvant therapy for locally advanced gastric cancer (GC) or gastro-oesophageal junction adenocarcinoma (GEJ): a multicentre, phase II, single-arm, open-label clinical trial (FRUTINEOGA) protocol. BMJ Open. 2024 Feb 10;14(2):e075696. doi: 10.1136/bmjopen-2023-075696.

  PMID: 38341203 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Yuzhou Qin

CONTACT

+867715310421; qyz402@126.com

Liucheng Wu

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: November 5, 2021
• Primary Completion: November 5, 2024
• Study Completion: November 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)