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Modified XELOX + sintilimab for Stomach Cancer

Phase 3
Recruiting
Led By Ruihua Xu, MD
Research Sponsored by Sun Yat-sen University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up an average of 4 years
Awards & highlights

Summary

This is a randomized, controlled, multicenter phase Ⅲ study to evaluate the therapeutic efficacy of modified XELOX plus sintilimab versus standard XELOX plus sintilimab in subjects with advanced HER2-negative gastric or gastroesophageal adenocarcinoma in the first-line treatment. The primary outcome is the progression-free survival (PFS), with a planned enrollment of 540 subjects.

Eligible Conditions
  • Stomach Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~an average of 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival (PFS)
Secondary outcome measures
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-STO22 (EORTC QLQ- STO22)
Disease Control Rate (DCR)
+3 more

Side effects data

From 2019 Phase 2 trial • 213 Patients • NCT01498289
72%
Fatigue
71%
Anemia
69%
Diarrhea
63%
Nausea
52%
Hypoalbuminemia
47%
Anorexia
45%
Vomiting
42%
White blood cell decreased
41%
Abdominal pain
37%
Hyperglycemia
36%
Hyponatremia
36%
Dehydration
35%
Hypocalcemia
34%
Constipation
33%
Weight loss
32%
Hypokalemia
32%
Alkaline phosphatase increased
31%
Neutrophil count decreased
31%
Alopecia
29%
Aspartate aminotransferase increased
27%
Lymphocyte count decreased
26%
Edema limbs
23%
Dysphagia
21%
Cough
20%
Alanine aminotransferase increased
20%
Dizziness
20%
Dyspnea
19%
Dysgeusia
19%
Hypotension
18%
Peripheral sensory neuropathy
17%
Generalized muscle weakness
16%
Anxiety
15%
Hypertension
13%
Insomnia
13%
Creatinine increased
12%
Fever
12%
Platelet count decreased
12%
Arthralgia
12%
Back pain
10%
Dry skin
10%
Blood bilirubin increased
9%
Hypomagnesemia
9%
Mucositis oral
9%
Sinus tachycardia
9%
Depression
9%
Headache
8%
Flatulence
7%
Rash maculo-papular
7%
Thromboembolic event
7%
CD4 lymphocytes decreased
7%
Hyperkalemia
7%
Hiccups
7%
Dyspepsia
6%
Pleural effusion
6%
Non-cardiac chest pain
6%
Sepsis
6%
Pruritus
6%
Pain in extremity
6%
Esophagitis
6%
Allergic rhinitis
6%
Febrile neutropenia
6%
Pain
5%
Hyperhidrosis
5%
Chills
5%
Neoplasms benign, malignant and unspecified - Other
5%
Upper respiratory infection
5%
Myalgia
5%
Watering eyes
5%
Epistaxis
5%
Rash acneiform
5%
Bloating
4%
Productive cough
4%
Esophageal pain
4%
Gastroesophageal reflux disease
4%
Hypoglycemia
4%
Hypophosphatemia
4%
Nail discoloration
4%
Blurred vision
4%
Ascites
4%
Infections and infestations-Other
4%
Nail ridging
4%
Hypernatremia
4%
Syncope
4%
Death NOS
4%
Stomach pain
4%
Skin infection
3%
Urinary frequency
3%
Paresthesia
3%
Voice alteration
3%
Dry eye
3%
Tooth infection
3%
Acute kidney injury
3%
Bone pain
3%
Metabolism and nutrition disorders - Other, specify
3%
Abdominal distension
3%
Glucose intolerance
3%
Chronic kidney disease
3%
Sore throat
3%
Dry mouth
3%
Eye disorders-Other
3%
Gastrointestinal disorders-Other
3%
Fall
3%
Allergic reaction
3%
INR increased
2%
Oral pain
2%
Investigations-Other
2%
Activated partial thromboplastin time prolonged
2%
Muscle weakness lower limb
2%
Urinary retention
2%
Memory impairment
2%
Confusion
2%
Ataxia
2%
Multi-organ failure
2%
Hypoxia
2%
Respiratory failure
2%
Upper gastrointestinal hemorrhage
2%
Lung infection
2%
Mucosal infection
2%
Weight gain
2%
Hypercalcemia
2%
Dysphasia
2%
Nasal congestion
2%
Nail loss
2%
Infusion related reaction
2%
Sinus pain
2%
Leukocytosis
2%
Ileus
2%
Proteinuria
2%
Palmar-plantar erythrodysesthesia syndrome
2%
Hot flashes
2%
Lipase increased
2%
Tremor
2%
Gastrointestinal pain
2%
Edema face
2%
Cholesterol high
2%
Malaise
2%
Localized edema
2%
Bladder infection
1%
Heart failure
1%
Nipple deformity
1%
Hypersomnia
1%
Bronchopulmonary hemorrhage
1%
Pneumonitis
1%
Resp, thoracic and mediastinal disorders - Other
1%
Urticaria
1%
Pleuritic pain
1%
Eye infection
1%
Serum amylase increased
1%
Hypermagnesemia
1%
Atelectasis
1%
Hemorrhoids
1%
Jejunal stenosis
1%
Sinus disorder
1%
Sinus bradycardia
1%
Endocrine disorders-Other
1%
Gastric hemorrhage
1%
Gallbladder pain
1%
Otitis media
1%
Ejection fraction decreased
1%
Chest wall pain
1%
Joint effusion
1%
Cognitive disturbance
1%
Pain of skin
1%
Flushing
1%
Hematoma
1%
Portal vein thrombosis
1%
Hearing impaired
1%
Fecal incontinence
1%
Obstruction gastric
1%
Enterocolitis infectious
1%
Urinary tract infection
1%
Injection site reaction
1%
Buttock pain
1%
Peripheral motor neuropathy
1%
Muscle weakness upper limb
1%
Hypothyroidism
1%
Anal fistula
1%
Tumor pain
1%
Esophageal hemorrhage
1%
Gastritis
1%
Musculoskeletal and connective tiss disorder - Other
1%
Neck pain
1%
Testicular pain
1%
Aspiration
1%
Hoarseness
1%
Pharyngeal mucositis
1%
Wheezing
1%
Skin ulceration
1%
Depressed level of consciousness
1%
Postnasal drip
1%
Vitreous hemorrhage
1%
Vascular disorders-Other
1%
Gastroparesis
1%
Malabsorption
1%
Edema trunk
1%
Small intestinal obstruction
1%
Rhinitis infective
1%
Tracheitis
1%
Gait disturbance
1%
Peritoneal infection
1%
Vascular access complication
1%
Wound infection
1%
Lip infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II IT
Arm I FOLFOX

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Modified XELOX + sintilimabExperimental Treatment1 Intervention
The treatment option for the modified XELOX group (study group) is 200 mg of sintilimab IV Drip Q3W, 600 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 78 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years.
Group II: Standard XELOX + sintilimabActive Control1 Intervention
The treatment option for the standard XELOX group (control group) is 200 mg of sintilimab IV Drip Q3W, 1000 mg/m2 of capecitabine PO BID for day 1-14, and oxaliplatin 130 mg/m2 IV Drip Q3W. After 6 cycles of treatment, patients could choose capecitabine + sintilimab maintenance with a maximum treatment duration of 2 years.

Find a Location

Who is running the clinical trial?

Sun Yat-sen UniversityLead Sponsor
1,577 Previous Clinical Trials
3,486,973 Total Patients Enrolled
Ruihua Xu, MDPrincipal InvestigatorSun Yat-sen University
9 Previous Clinical Trials
1,644 Total Patients Enrolled
~327 spots leftby Dec 2026
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