Actively Recruiting
Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Led by Zuoyi Jiao · Updated on 2025-04-22
682
Participants Needed
4
Research Sites
298 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the efficacy and safety of neoadjuvant apatinib combined with sintilimab and perioperative SOX chemotherapy versus neoadjuvant sintilimab combined with perioperative SOX chemotherapy in locally advanced intestinal-type gastric cancer/gastroesophageal junction adenocarcinoma. The primary questions include: 1. Whether the complete remission rate (pCR) of the apatinib combined with sintilimab and SOX regimen is higher than that of the sintilimab combined with SOX regimen. 2. The safety of the apatinib combined with sintilimab and SOX regimen. Participants will be divided into: 1. Experimental Group: Participants will receive an intravenous injection of sintilimab (200 mg) combined with the SOX regimen (oxaliplatin 130 mg/m² and S-1, with the initial dose determined based on body surface area). Additionally, apatinib (250 mg) will be administered orally once daily during the first three neoadjuvant cycles. 2. Control Group: Participants will receive treatment with the sintilimab combined with the SOX regimen. This treatment will be administered for three to four cycles prior to surgery, followed by radical surgery, including D2 or D2+ lymph node dissection. Surgery is scheduled four weeks after the last neoadjuvant therapy (NAT) cycle. Within 3 to 6 weeks post-surgery, patients will begin adjuvant SOX chemotherapy. Postoperative patients will receive four cycles of adjuvant SOX chemotherapy, administered every three weeks.
CONDITIONS
Official Title
Neoadjuvant Apatinib Combined With Sintilimab and Perioperative SOX Versus Neoadjuvant Sintilimab Combined With Perioperative SOX for Intestinal Type of Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have a pathologically confirmed HER-2 negative intestinal type gastric or gastroesophageal junction adenocarcinoma.
- Locally advanced disease (clinical stage cT2 to cT4), lymph nodes N0 to N3, no metastatic disease (M0).
- Patients with Siewert type 2 or 3 tumors, and select type 1 tumors planned for perioperative chemotherapy and surgery.
- Male or female aged 18 to 75 years at consent.
- Expected survival of at least 12 weeks.
- ECOG performance status of 0 or 1.
- Use of effective contraception for sexually active males and females of childbearing potential during and for 120 days after treatment.
- Adequate blood counts, liver, kidney, coagulation, and cardiac function.
- No prior anti-tumor treatment including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
- Willingness to provide tumor tissue and blood samples at baseline and surgery.
- Plan to proceed to surgery after preoperative chemotherapy as per standard care.
- Provision of written informed consent.
You will not qualify if you...
- History of pneumonitis requiring steroids or current pneumonitis.
- Active infections requiring systemic therapy.
- Active autoimmune diseases requiring systemic treatment within 2 years, excluding certain stable conditions.
- Systemic corticosteroid or immunosuppressive treatment within 14 days before first dose, except replacement therapy.
- History of primary immunodeficiency.
- Receipt of live vaccines or immune-activating anti-tumor drugs within 30 days before study treatment.
- Known active tuberculosis.
- History of allogeneic organ or hematopoietic stem cell transplantation.
- Severe allergy or hypersensitivity to study drugs or their components.
- Significant cardiovascular or cerebrovascular diseases or risk factors as detailed.
- Participation in another interventional clinical study.
- Prior systemic anti-tumor therapy.
- Prior treatment with anti-PD-1, anti-PD-L1, or other checkpoint inhibitors.
- Confirmed HER-2 positive tumor.
- Unable to provide required tumor or blood samples.
- Pregnant or lactating women, or women planning pregnancy within 5 months of study; must have a negative pregnancy test before enrollment.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Actively Recruiting
2
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
3
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
4
The Gastrointestinal Surgery Department, Sun Yat-sen University Cancer Center Gansu Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
Research Team
B
Bo Long
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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