Actively Recruiting
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
Led by Henan Cancer Hospital · Updated on 2025-07-17
70
Participants Needed
1
Research Sites
226 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on the current status and progress in the treatment of gastric cancer, our center prospectively designed a first-line comprehensive treatment plan for unresectable or postoperative recurrent advanced gastric/gastroesophageal conjoint adenocarcinoma, fruquintinib + sintilimab + oxaliplatin + Capecitabine (CAPEOX), which utilizes the tumor immunomodulation and vascular normalization effects of fruquintinib. While improving the effective perfusion of intravenous chemotherapy with CAPEOX regimen, further combining with PD-1 monoclonal antibody to regulate the immunosuppressive microenvironment and reactivate the anti-tumor immune response of the body. An exploratory dose-climbing trial was designed to evaluate the clinical efficacy and safety of fruquintinib in combination with Sintilimab and CAPEOX in clinical practice. At the same time, changes in genome, pathology and immune microenvironment of tumor-related tissues before and after treatment were observed, and molecular markers related to curative effect were screened to explore the molecular mechanism affecting the curative effect of combination therapy, and further enrichment of therapeutic advantage groups to improve the surgical conversion rate laid the foundation for future large-scale clinical studies
CONDITIONS
Official Title
Fruquintinib in Combination With Sintilimab and CAPEOX as First-line Treatment for G/GEJ Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years
- Willing and able to understand the study and provide written informed consent
- Diagnosed with incurable advanced or recurrent gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or cytology, HER2-negative or unknown status
- Have at least one measurable tumor lesion according to RECIST 1.1 criteria
- No prior treatment with VEGFR-targeting drugs or PD-1/PD-L1 monoclonal antibodies; prior adjuvant chemo with platinum, paclitaxel, or fluorouracil allowed if recurrence occurred more than 6 months after treatment without grade 2 or higher toxicity
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- Adequate organ function with specified blood counts, liver enzymes, kidney function, heart function (LVEF ≥ 50%), and normal thyroid function within 14 days before randomization
- Weight of at least 40 kg or BMI over 18.5
- Women of childbearing potential must have a negative pregnancy test within 7 days before randomization and agree to use effective contraception during the study and for specified periods after treatment
- Men who are not sterilized must agree to use effective contraception during the study and for specified periods after treatment
You will not qualify if you...
- History of other cancers except early tumors judged unlikely to affect short-term survival (e.g., skin basal cell carcinoma, cervical carcinoma in situ, stage I lung or colorectal cancer)
- Participation in other drug clinical trials within 4 weeks
- Conditions affecting oral medication intake such as inability to swallow, chronic diarrhea, or intestinal obstruction
- History of bleeding events with severe grade within 4 weeks before screening
- Known or suspected central nervous system metastases unless ruled out by recent imaging
- Uncontrolled hypertension or serious heart conditions including recent angina or infarction, significant arrhythmias, or advanced heart failure
- Long-term unhealed wounds or fractures
- Tumor invasion into major blood vessels or high risk of fatal bleeding
- Abnormal blood clotting or bleeding tendencies; recent use of anticoagulants except low-dose aspirin or warfarin for prophylaxis
- Recent arteriovenous thrombosis events within 6 months
- Significant urinary protein detected
- Prior use of immunotargeted therapy drugs
- History of immunodeficiency or organ transplantation
- Current infectious or non-infectious pneumonia requiring steroids
- History of serious autoimmune or inflammatory diseases, active infections including hepatitis B, C, or HIV
- Allergy to monoclonal antibodies
- History of psychotropic drug abuse or uncontrolled mental disorders
- Clinical symptoms from pleural or abdominal effusion requiring intervention
- Non-compliance with medical advice or incomplete data affecting study evaluation
- Serious concomitant diseases risking safety or study completion as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
Actively Recruiting
Research Team
X
Xiaobing Chen
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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