Gastric CancerPhase 2NCT05122091
Fruquintinib Plus SOX as Neoadjuvant Therapy for Locally Advanced Gastric Adenocarcinoma
A Phase 2 study testing Fruquintinib + SOX in people with Gastric Cancer and GastroEsophageal Cancer, run by Guangxi Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, GastroEsophageal Cancer, Fruquintinib
- What is being tested?
- Fruquintinib + SOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2021to 30 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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;
Who cannot join
- 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;
- 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;
- 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;
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- 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%;
- Active infection or serious infection that is not controlled by drug (≥CTCAE v5.0 Grade 2）;
- 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;
- 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;
- Women who are pregnant or lactating;
- With blood transfusion or any blood component or cell growth factor within 14 days prior to enrollment;
- 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;
- Urine routine indicates urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0 g;
- Patients considered unsuitable for inclusion in this study by the investigator.
Trial locations and contacts
1 site in 1 country.
Liucheng Wu contact
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning
Yuzhou Qin, Ph.D, +867715310421, qyz402@126.com
Liucheng Wu, Ph.D, wuliucheng@gxmu.edu.cn
About this study
Official title: 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
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.
Read the detailed description
Gastric cancer (GC) is one of the leading causes of cancer-related deaths worldwide and a substantial global health burden. Surgery is the only possible way to cure gastric cancer, however, more than 80% of Chinese patients are diagnosed at advanced stages. Surgery and comprehensive treatment have made significant progress in gastric/gastroesophageal junction adenocarcinoma, but recurrence and metastasis are still common. Improving the R0 resection rate and reducing recurrence and metastasis rates are becoming more urgent. 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 single-arm, multicenter, open-label phase II study is designed to evaluate the efficacy and safety of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received prior antitumor therapy.
- Conditions
- Gastric Cancer, GastroEsophageal Cancer, Fruquintinib, SOX
- Being tested
- Fruquintinib + SOX
- Keywords
- Gastric cancer, Fruquintinib, Neoadjuvant, SOX
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib + SOXDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Fruquintinib + SOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological remission rate (PRR)
Rate of patients with < 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline
Measured: Approximately 2 years
Secondary outcomes (5)
Disease free survival (DFS)
Disease free survival Time from randomization to relapse or death from any cause
Measured: Approximately 2 years
Overall Survival (OS)
Overall survival Time from randomization to death from any cause
Measured: Approximately 2 years
Objective response rate (ORR)
Rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1
Measured: Approximately 2 years
Major pathological response rate (MPR)
Less than 10% residual carcinoma cells in the specimen
Measured: 30 days
R0 resection rate
Evaluation of the resection margin status (positive or negative) in the rectal specimen
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start5 Nov 2021
- Primary completion5 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Liucheng, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122091
- Sponsor's protocol ID
- FRUTINEOGA
- Status last verified
- Feb 2024
- First submitted
- 4 Nov 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38341203
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05122091
- Acronym / sponsor ID
- FRUTINEOGA
- Conditions
- Gastric Cancer, GastroEsophageal Cancer, Fruquintinib, SOX
- Keywords
- Gastric cancer, Fruquintinib, Neoadjuvant, SOX
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Gastric cancer (GC) is one of the leading causes of cancer-related deaths worldwide and a substantial global health burden. Surgery is the only possible way to cure gastric cancer, however, more than 80% of Chinese patients are diagnosed at advanced stages. Surgery and comprehensive treatment have made significant progress in gastric/gastroesophageal junction adenocarcinoma, but recurrence and metastasis are still common. Improving the R0 resection rate and reducing recurrence and metastasis rates are becoming more urgent. 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 single-arm, multicenter, open-label phase II study is designed to evaluate the efficacy and safety of Fruquintinib plus SOX as neoadjuvant therapy for locally advanced gastric or gastroesophageal junction adenocarcinoma who have not received prior antitumor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fruquintinib group | Experimental | Drug: Fruquintinib + SOXTwo-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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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；
Key exclusion criteria (24 listed)
- 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;
- 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;
- Patients with any active autoimmune disease or a documented history of autoimmune disease within 4 weeks prior to enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruquintinib + SOXFruquintinib：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. | Drug | Fruquintinib group |
Primary outcome
Pathological remission rate (PRR)
Time frame: Approximately 2 years
Rate of patients with < 2/3 residual tumor lesion (Grade 1b, 2, 3) in surgical specimen compared to baseline
5 secondary outcomes
Disease free survival (DFS)
Time frame: Approximately 2 years
Overall Survival (OS)
Time frame: Approximately 2 years
Objective response rate (ORR)
Time frame: Approximately 2 years
Major pathological response rate (MPR)
Time frame: 30 days
R0 resection rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 38341203Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liucheng Wu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib + SOX in people with Gastric Cancer and GastroEsophageal Cancer, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuzhou Qin (+867715310421, qyz402@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological remission rate (PRR) (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.