Actively Recruiting
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
Led by Xiaofeng Chen · Updated on 2023-11-30
43
Participants Needed
1
Research Sites
161 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Able to understand study steps and voluntarily sign informed consent
- Histologically or cytologically confirmed HER2-negative or unknown status gastric or gastroesophageal junction adenocarcinoma
- Metastasis limited to liver (up to 5 lesions, each ≤5 cm) and/or retroperitoneal lymph nodes (specific stations 16a2, 16b1, 16a1, 16b2) only, with no other distant metastases
- At least one measurable lesion per RECIST 1.1 criteria
- No prior treatment with VEGFR-targeted drugs or PD-1/PD-L1 antibodies; previous adjuvant chemotherapy allowed if relapse occurred >6 months after completion without significant toxicity
- ECOG performance status 0-1
- Expected survival of at least 3 months
- Adequate organ function within 14 days prior to enrollment including blood counts, liver and kidney function, cardiac function (LVEF ≥50%), thyroid function, and body weight ≥40 kg or BMI >18.5
You will not qualify if you...
- History of other malignant tumors unless cured early-stage tumors that do not affect short-term survival
- Participation in other drug trials within 4 weeks
- Conditions affecting oral medication intake
- Recent history of severe bleeding or bleeding disorders
- Presence of metastases outside liver and retroperitoneal lymph nodes (e.g., lung, brain, bone, peritoneum)
- Uncontrolled hypertension or significant cardiac disease including recent angina or infarction, arrhythmias requiring long-term treatment, or NYHA grade ≥II heart dysfunction
- Long-term unhealed wounds or fractures
- Tumor invasion of major blood vessels with high risk of fatal bleeding
- Abnormal coagulation or anticoagulant medication use beyond low-dose warfarin or aspirin
- Recent arterial or venous thrombosis events
- Significant proteinuria
- Previous immune-targeted therapy
- History of immunodeficiency or organ transplantation
- Active pneumonia or interstitial lung disease requiring steroids
- Severe autoimmune diseases or active infections including hepatitis B/C or HIV
- Hypersensitivity to monoclonal antibodies
- History of psychotropic drug abuse or mental disorders
- Noncompliance with medication or incomplete data
- Serious comorbid conditions compromising safety or study completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Jiangsu Province Hospita
Nanjin, China
Actively Recruiting
Research Team
C
Chen xiao feng, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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