Actively Recruiting
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Led by Xijing Hospital · Updated on 2026-04-23
116
Participants Needed
5
Research Sites
97 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital
Lead Sponsor
T
Tang-Du Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multicenter, double-blind, randomized, phase 2 trial to investigate the efficacy and safety of serlulimab combined with nab-paclitaxel plus SOX versus nab-paclitaxel plus SOX alone as neoadjuvant treatment for locally advanced GC or AEG. The goal of this clinical trial is to learn if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. It will also learn about the safety of serlulimab combined with nab-paclitaxel plus SOX. The main questions it aims to answer are: Does serlulimab increase the pCR of participants with locally advanced AEG/GC ? What medical problems do participants have when taking serlulimab? Researchers will compare to a placebo (a look-alike substance that contains no drug) to see if serlulimab combined with nab-paclitaxel plus SOX as neoadjuvant treatment for locally advanced AEG/GC. Participants will: Eligible patients were randomly assigned to receive serlulimab (4.5 mg intravenously on day 1) combined with chemotherapy (nap-paclitaxel 260 mg/m2 intravenously on days 1, OXA 130mg/ /m2, intravenously on days 1, and S-1 40 to 60 mg orally twice daily depending on BSA on days 1 to 14) or chemotherapy alone every 3 weeks for 3 preoperative cycles followed by 3 postoperative cycles. All patients will be followed for survival.
CONDITIONS
Official Title
Efficacy and Safety of Serplulimab Combined With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 18 and younger than 75 years
- Primary gastric cancer or adenocarcinoma of the esophagogastric junction (Siewert II/III) confirmed by endoscopic biopsy
- Clinical stage T3 or T4 with lymph node involvement and no distant metastasis assessed by CT, MRI, PET-CT, and laparoscopy if feasible
- At least one measurable lesion according to RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Planned surgical treatment after neoadjuvant chemotherapy based on clinical staging
- Life expectancy of at least 3 months
- Acceptable bone marrow, liver, and kidney function with specified blood counts and enzyme levels
- Written informed consent
You will not qualify if you...
- Diagnosed with squamous cell carcinoma, adenosquamous cell carcinoma, small cell carcinoma, or undifferentiated gastric cancer
- Positive Her-2 detection (IHC3+ or IHC2+ amplified by FISH)
- Prior chemotherapy, radiotherapy, hormone therapy, targeted therapy, or immunotherapy
- Contraindications to surgery or chemotherapy
- Presence of distant metastasis
- History of other malignant diseases within the past 5 years except certain treated skin or cervical cancers
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive medications except vitiligo or resolved childhood asthma/atopy
- History of immunodeficiency diseases including HIV or transplantation
- Severe mental disorder
- Presence of digestive tract obstruction, jaundice, acute infections, inflammatory bowel disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active tuberculosis
- Use of immunosuppressive drugs within 2 weeks or during the study period with specified exceptions
- Major surgery or live virus vaccine within 4 weeks
- Pregnancy, breastfeeding, or unwillingness to use contraception during treatment and 6 months after
- Evidence of bleeding tendency or use of thrombolytics or anticoagulants
- Symptoms matching Common Adverse Events criteria (NCI-CTCAE V5.0)
- Positive hepatitis B or C tests meeting defined viral load thresholds
- Allergic to study drugs
- Other conditions affecting protocol adherence or evaluation suitability as judged by investigator
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Trial Site Locations
Total: 5 locations
1
The fourth hospital of Hebei Medical University
Shijiazhuang, Heibei Province, China, 050000
Actively Recruiting
2
Department of Digestive surgery, Xijing Hospital of Digestive Diseases, Air Force Medical University, Xi' an, China
Xi'an, Shaanxi, China, 710032
Actively Recruiting
3
Department of General Surgery, Tangdu Hospital, Air Force Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
4
Department of General Surgery, The 986th Military Hospital, Air Force Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
5
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China, 300060
Actively Recruiting
Research Team
Z
Zhenshun Li, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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