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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study

XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study ( FISSION Study )

XELOX Combined With Fruquintinib and Sintilimab Regimen Conversion Therapy for Gastric Cancer/Gastroesophageal Junction Adenocarcinoma Only With Liver and/or Retroperitoneal Lymph Node Metastasis, a Prospective Single-arm, Multicenter Study (NCT06091423) is a Phase 2 interventional studying Gastric Cancer/Gastroesophageal Junction Adenocarcinoma, sponsored by Xiaofeng Chen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Gastric cancer is the third leading cause of morbidity and mortality among malignant tumors in China, and less than 30% of patients can be cured by surgery. Liver metastasis, retroperitoneal lymph node metastasis and peritoneal metastasis are the most common metastatic sites of gastric cancer, which are also the important causes of death. Improve the conversion of oligonucleotides transfer patients resection rate, prolonged progression-free survival of these patients, is an important direction to improve survival of patients with advanced gastric cancer; This study was a prospective, single-arm, multi-center clinical study. We plan to treat patients with gastric cancer/gastroesophageal junction adenocarcinoma with liver and/or retroperitoneal lymph node metastasis only with XELOX regimen + fruquinitinib + sintilimab for 4-6 cycles before surgery/ablation conversion therapy to achieve tumor-free status as far as possible. To explore the value of conversion therapy in patients with intrahepatic oligometastasis of gastric cancer.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer/Gastroesophageal Junction Adenocarcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 43 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age: 18-75 years of age; 2. Understand the steps and content, and written willing to sign a consent form signed voluntarily; 3. Is confirmed by histopathology and/or cytology her2-negative or HER2 status unknown late recurrence or stomach esophagus stomach/integration of adenocarcinoma; 4. In this research to define transfer of oligonucleotides definition: the primary lesion and regional lymph node metastasis of process to determine the surgeon can be cut or boundary can be cut, only intrahepatic metastasis and distant metastasis (metastases number 5 or less, a single lesion or less 5 cm in diameter.) And or retroperitoneal lymph node metastasis (16a2,16b1,16a1,16b2 metastasis), no other distant metastasis; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. No previous treatment with VEGFR-targeted drugs and PD-1/PD-L1 monoclonal antibodies. Patients who had relapsed more than 6 months after the completion of postoperative adjuvant chemotherapy with platinum or paclitaxel or fluorouracil and had no grade 2 or higher toxicity were eligible for enrollment. 7. ECOG PS score: 0-1; 8. Expected survival time ≥3 months; 9. The main viscera function is good, namely into groups of related within 14 days before check index meet the following requirements: (1) blood count (hemoglobin) at least 80 g/L; (2) neutrophil count \>1.5×109/L; (3) platelet count ≥80×109/L; (4) Total bilirubin ≤2.5×ULN (upper limit of normal); (5) serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5×ULN; (6) the endogenous creatinine clearance or 60 ml/min (Cockcroft - Gault formula); (7) Echocardiography: left ventricular ejection fraction (LVEF)≥50%; (8) Thyroid function indexes: thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) were in the normal range or only mildly abnormal, without related clinical symptoms; (9) A body weight of 40 kg or more, or a BMI \> 18.5; Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age: 18-75 years of age; 2. Understand the steps and content, and written informed consent signed voluntarily; 3. Is confirmed by histopathology and/or cytology her2-negative or HER2 status unknown late recurrence or stomach esophagus stomach/integration of adenocarcinoma; 4. In this research to define transfer of oligonucleotides definition: the primary lesion and regional lymph node metastasis of process to determine the surgeon can be cut or boundary can be cut, only intrahepatic metastasis and distant metastasis (metastases number 5 or less, a single lesion or less 5 cm in diameter.) And or retroperitoneal lymph node metastasis (16a2,16b1,16a1,16b2 metastasis), no other distant metastasis; 5. At least one measurable lesion according to RECIST 1.1 criteria; 6. No previous treatment with VEGFR-targeted drugs and PD-1/PD-L1 monoclonal antibodies. Patients who had relapsed more than 6 months after the completion of postoperative adjuvant chemotherapy with platinum or paclitaxel or fluorouracil and had no grade 2 or higher toxicity were eligible for enrollment. 7. ECOG PS score: 0-1; 8. Expected survival time ≥3 months; 9. The main viscera function is good, namely into groups of related within 14 days before check index meet the following requirements: (1) hemoglobin ≥80 g/L; (2) neutrophil count \>1.5×109/L; (3) platelet count ≥80×109/L; (4) Total bilirubin ≤2.5×ULN (upper limit of normal); (5) serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤5×ULN; (6) the endogenous creatinine clearance or 60 ml/min (Cockcroft - Gault formula); (7) Echocardiography: left ventricular ejection fraction (LVEF)≥50%; (8) Thyroid function indexes: thyroid stimulating hormone (TSH) and free thyroxine (FT3/FT4) were in the normal range or only mildly abnormal, without related clinical symptoms; (9) A body weight of 40 kg or more, or a BMI \> 18.5; Exclusion Criteria: 1. Patients with other malignant tumors in the past or at the same time, but have been cured of early tumors, including basal cell carcinoma of the skin and carcinoma in situ of the cervix, stage I lung cancer, stage I colorectal cancer and other tumors that do not affect the patient's life in the short term according to the investigator's judgment can be excluded; 2. Participated in other drug clinical trials within four weeks; 3. Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 4. Patients with a history of bleeding and any bleeding events of CTCAE5.0 grade 3 or higher within 4 weeks before screening; 5. Metastasis in other distant sites, including but not limited to lung metastasis, brain metastasis, bone metastasis, distant lymph node metastasis, and peritoneal metastasis; 6. Patients with hypertension not well controlled by single antihypertensive medication (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg); Patients with a history of unstable angina; Newly diagnosed angina pectoris within 3 months before screening or myocardial infarction within 6 months before screening; Arrhythmias (including QTcF ≥450 ms in men and ≥470 ms in women) required long-term use of antiarrhythmic drugs and New York Heart Association (NYHA) grade ≥II cardiac dysfunction; 7. Long-term unhealed wounds or incompletely healed fractures; 8. Imaging shows that the tumor has invaded the important blood vessels or the investigator judges that the patient's tumor has a high possibility of invading the important blood vessels during the treatment and causing fatal hemorrhage; 9. Abnormal coagulation function, with bleeding tendency (14 days before enrollment must meet: INR in the normal range without anticoagulant or clinically insignificant abnormality); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; International standardization in prothrombin time ratio (INR) under the premise of 1.5 or less, allowing purpose to prevent the use of low-dose warfarin (1 mg orally, once per day) or low-dose aspirin (amount does not exceed 100 mg daily); 10. Occurrence of arterial/venous thrombosis events within 6 months before screening, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for venous thrombosis caused by venous catheterization due to previous chemotherapy and judged by investigators to be cured), and pulmonary embolism; 11. Urine routine showed urine protein ≥++ and confirmed 24-hour urine protein quantitation \>1.0 g; 12. Previous use of immune-targeted therapy drugs; 13. Have a history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 14. Patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; 15. A history of severe chronic autoimmune diseases, such as systemic lupus erythematosus; He had a history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, and a history of chronic diarrhea such as irritable bowel syndrome. A history of sarcoidosis or tuberculosis; Patients with a history of active hepatitis B or C, and HIV infection; Good control of severe autoimmune disease, such as dermatitis, arthritis, psoriasis, etc can be into the group. Patients with hepatitis B virus titer \<1000copy/ml were eligible for enrollment. 16. Patients with hypersensitivity to human or murine monoclonal antibodies; 17. Have a history of psychotropic drug abuse and cannot quit or have mental disorders; 18. Patients who do not follow the doctor's advice, do not follow the prescribed medication, or have incomplete data, which may affect the efficacy or safety judgment; 19. Concomitant diseases that, in the judgment of the investigator, seriously compromise patient safety or interfere with patient completion of the study.

Treatments Being Tested

DRUG

XELOX combined with Fruquintinib and Sintilimab

XELOX:Capecitabine:800mg/m2, po, bid, d1-14。Oxaliplatin:130mg/m2,ivgtt 2-6h,d1,q3w; Fruquintinib: 5 mg/d,qd po,d1-14,q3w; Sintilimab: 200mg d1, q3w

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jiangsu Province Hospita
Nanjin, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06091423), the sponsor (Xiaofeng Chen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06091423 clinical trial studying?

Gastric cancer is the third leading cause of morbidity and mortality among malignant tumors in China, and less than 30% of patients can be cured by surgery. Liver metastasis, retroperitoneal lymph node metastasis and peritoneal metastasis are the most common metastatic sites of gastric cancer, which are also the important causes of death. Improve the conversion of oligonucleotides transfer patients resection rate, prolonged progression-free survival of these patients, is an important direction to improve survival of patients with advanced gastric cancer; This study was a prospective, single-a… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06091423?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06091423?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06091423. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06091423. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.