Actively Recruiting
Nivolumab Combined With SOX Used in the Perioperative Treatment
Led by Xiangdong Cheng · Updated on 2024-07-09
46
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the pathological complete response rate (pCR) of nivolumab combined with SOX (oxaliplatin + S-1) for neoadjuvant therapy of resectable gastric and gastroesophageal junction adenocarcinoma;
CONDITIONS
Official Title
Nivolumab Combined With SOX Used in the Perioperative Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma
- Clinical stage cT3-4 or N+, M0 suitable for radical surgery as determined by CT and laparoscopy
- No prior anti-tumor therapy such as surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy
- Planned surgery following neoadjuvant therapy
- Able to normally swallow tablets
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 months
- Normal main organ function including blood counts and liver/kidney function within specified limits
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 120 days after last dose
- Male participants with partners of childbearing potential must agree to use effective contraception during the study and for 120 days after last dose
You will not qualify if you...
- Unresectable tumor or surgical contraindications or refusal of surgery
- History or presence of other malignancies
- Serious chronic illnesses intolerable to treatment such as severe cardiac disease or uncontrolled hypertension
- Previous gastrointestinal perforation, abdominal abscess, or recent intestinal obstruction within 3 months
- Significant bleeding symptoms or bleeding tendencies within 3 months prior to study drug
- Active infection requiring treatment
- Active hepatitis B or C infection
- Congenital or acquired immunodeficiency including HIV infection
- Active or history of autoimmune disease with risk of relapse
- Planned or prior organ or bone marrow transplant
- Current or past interstitial lung disease or active pneumonia with severe lung impairment
- Recent or ongoing immunosuppressive or corticosteroid therapy
- Recent live attenuated vaccine use or requirement during study
- Known allergy to study drugs or their components
- Nursing mothers
- Any other condition judged by the investigator to compromise patient safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
C
Cheng Xiangdong
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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