Actively Recruiting
Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma
Led by Renmin Hospital of Wuhan University · Updated on 2022-10-03
29
Participants Needed
1
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Prospective, Single-center, Single-arm, phase II clinical trial to explore the efficacy and safety of sintilimab (PD1 inhibitor) combined with XELOX chemotherapy, evaluate the pathological complete response rate of short-course radiotherapy combined with sintilimab and XELOX chemotherapy in neoadjuvant therapy for locally advanced gastric adenocarcinoma.
CONDITIONS
Official Title
Short-course Radiotherapy Combined With Neoadjuvant Chemotherapy and PD-1 Inhibitor in the Treatment of Locally Advanced Gastric Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Aged between 18 and 75 years
- Histologically confirmed stage III gastric adenocarcinoma (cT3-4aN1-3 M0) with resectable lesions
- No previous systemic therapy including surgery, radiotherapy, chemotherapy, or immunotherapy
- No contraindications and consent to radical surgery
- Eastern Cooperative Group (ECOG) performance status score of 0 or 1
- Expected survival time greater than 6 months
- Normal main organ function meeting specific laboratory criteria including neutrophil count, platelets, hemoglobin, liver and kidney function, coagulation, and thyroid function
- Female subjects of reproductive age must have a negative pregnancy test within 3 days before first drug administration
- Use of effective contraception during treatment and up to 120 days after last study drug administration (180 days for chemotherapy)
You will not qualify if you...
- History of other malignancies within 5 years except certain skin cancers and carcinoma in situ treated with radical resection
- Active bleeding in the lesion
- Participation in other interventional clinical studies or use of study drugs/devices within 4 weeks prior to study drug administration
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint inhibitors
- Use of systemic Chinese patent drugs or immunomodulatory agents with anti-tumor indications within 2 weeks before study drug administration
- Active autoimmune disease requiring systemic therapy within 2 years
- Recent use of systemic glucocorticoids or immunosuppressive therapy within 7 days before study drug administration
- History of allogeneic organ or stem cell transplantation (except corneal)
- Known allergy to drugs used in the study
- Inability to take Capecitabine orally
- Failure to recover from prior treatment toxicities to baseline or grade 1 adverse events (except fatigue and hair loss)
- Known HIV infection
- Untreated active hepatitis B or active hepatitis C infection
- Receipt of live vaccines within 30 days prior to study drug administration
- Pregnant or lactating women
- Severe or uncontrolled systemic diseases including serious heart conditions, unstable angina, recent arterial thrombosis or embolism, uncontrolled blood pressure, active pulmonary conditions, infections, gastrointestinal obstruction, liver diseases, poorly controlled diabetes, significant proteinuria, or mental disorders preventing cooperation
- Any other medical condition or abnormal test results that might interfere with study participation or results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430061
Actively Recruiting
Research Team
X
Xiangpan Li, M.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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