Gastric cancer.
Eric Van Cutsem, Xavier Sagaert, Baki Topal...
https://pubmed.ncbi.nlm.nih.gov/27156933Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06576921
Efficacy and Safety of Serplulimab Combined With Nab-paclitaxel and SOX as Neoadjuvant Treatment for Locally Advanced Gastric Cancer or Adenocarcinoma of Esophagogastric Junction: A Multicenter Randomized Controlled Trial
Led by Xijing Hospital · Updated on 2026-04-23
116
Participants Needed
5
Research Sites
17 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
Researchers are evaluating the effectiveness and safety of serlulimab combined with nab-paclitaxel plus SOX chemotherapy compared to nab-paclitaxel plus SOX alone as a pre-surgery treatment for patients with locally advanced gastric cancer (GC) or adenocarcinoma of the esophagogastric junction (AEG). This phase 2, multicenter, double-blind, randomized trial aims to determine whether serlulimab increases the pathological complete response rate and to assess the safety of this combination treatment. Gastric cancer is a serious and common cancer with poor prognosis, especially in eastern Asia, highlighting the need for improved treatment options.
CONDITIONS
Brief 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
Age: 18Years - 75Years
All Genders
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 as assessed by imaging 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 based on blood tests and coagulation function
- Written informed consent
You will not qualify if you...
- 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 for surgery or chemotherapy
- Presence of distant metastasis
- History of other cancers within 5 years except certain skin or cervical cancers treated successfully
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressive drugs, except vitiligo or resolved childhood asthma/atopy
- History of immunodeficiency diseases such as HIV or transplantation
- Severe mental disorder
- Digestive tract obstruction, jaundice, active 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 some exceptions
- Major surgery or live virus vaccine within 4 weeks
- Pregnant or breastfeeding, or unwilling to use effective contraception during and 6 months after treatment
- Bleeding tendency or use of blood thinners
- Allergic to study drugs
- Other conditions that may affect participation or study evaluation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Neoadjuvant Treatment
Duration - Approximately 9 weeks (three 3-week cycles)
Participants receive neoadjuvant treatment consisting of Serplulimab combined with nab-paclitaxel plus SOX chemotherapy or placebo combined with nab-paclitaxel plus SOX chemotherapy. Treatment cycles are given every 3 weeks for three preoperative cycles to reduce tumor size before surgery.
3 visits every 3 weeks (in-person)
Surgery
Duration - Surgery occurs 3 to 4 weeks after neoadjuvant treatment
Participants undergo surgery scheduled 3 to 4 weeks after completion of the neoadjuvant treatment phase. All surgical procedures follow specific clinical guidelines for gastric cancer.
1 visit (in-person surgery)
Adjuvant Treatment
Duration - Approximately 9 weeks (three 3-week cycles) starting 3 to 8 weeks after surgery
After surgery, participants receive adjuvant treatment consisting of three 3-week cycles of chemotherapy with either Serplulimab combined with nab-paclitaxel plus SOX or placebo combined with nab-paclitaxel plus SOX to help prevent cancer recurrence.
3 visits every 3 weeks (in-person)
Follow-up
Duration - Up to 3 years after treatment completion
Participants are monitored for safety, progression-free survival, overall survival, and other health outcomes following completion of treatment.
Periodic visits over 3 years
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
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Research Team
Z
Zhenshun Li, Ph.D
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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Published Research Related To This Trial
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Wanqing Chen, Rongshou Zheng, Peter D Baade...
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Parisa Karimi, Farhad Islami, Sharmila Anandasabapathy...
https://pubmed.ncbi.nlm.nih.gov/24618998Management of Helicobacter Pylori in the United States: Results from a national survey of gastroenterology physicians.
Traci T Murakami, Rebecca A Scranton, Heidi E Brown...
https://pubmed.ncbi.nlm.nih.gov/28457713Helicobacter pylori infection and the development of gastric cancer.
N Uemura, S Okamoto, S Yamamoto...
https://pubmed.ncbi.nlm.nih.gov/11556297Global burden of gastric cancer attributable to Helicobacter pylori.
Martyn Plummer, Silvia Franceschi, Jérôme Vignat...
https://pubmed.ncbi.nlm.nih.gov/24889903Defining surgical quality in gastric cancer: a RAND/UCLA appropriateness study.
Savtaj Brar, Calvin Law, Robin McLeod...
https://pubmed.ncbi.nlm.nih.gov/23664139Gastric cancer.
Elizabeth C Smyth, Magnus Nilsson, Heike I Grabsch...
https://pubmed.ncbi.nlm.nih.gov/32861308Correlation of pathological complete response with survival after neoadjuvant chemotherapy in gastric or gastroesophageal junction cancer treated with radical surgery: A meta-analysis.
Ziyu Li, Fei Shan, Yinkui Wang...
https://pubmed.ncbi.nlm.nih.gov/29370182Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial.
Marc Ychou, Valérie Boige, Jean-Pierre Pignon...
https://pubmed.ncbi.nlm.nih.gov/21444866