Actively Recruiting
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
Led by Wan He · Updated on 2025-02-05
62
Participants Needed
2
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastric cancer (GC),including cardia and noncardia gastric cancer, is responsible for over 480,000 new cases in 2020 and an estimated 370,000 deaths, making it the third most frequently diagnosed cancer and the third leading cause of cancer death in China. Majority of patients(63%) are presented with locally advanced gastric cancer (stage Ⅱ/Ⅲ) and the prognosis is poor. Previous studies have shown that patients with pathological complete response(pCR) following neoadjuvant therapy have longer survival. In 2019, Lancet Oncology published the FLOT4-AIO study which testified that perioperative chemotherapy with FLOT (5-FU/LV, oxaliplatin and docetaxel) regimen has improved pCR rate and prolonged progression free survival(PFS) and overall survival(OS) in patients with stage II/III gastric cancer. Moreover, PD-1 blockade such as nivolumab or pembrolizumab in combination with chemotherapy has shown higher objective response rate(ORR) as compared to chemotherapy alone in advanced gastric cancer. The nanoparticle albumin-bound paclitaxel has been recommended as the second-line chemotherapy for unresectable or recurrent gastric cancer based on the Chinese Society of Clinical Oncology(CSCO) guideline. When PD-1 antibody is applied, albumin-bound paclitaxel is considered as a better partner since no pretreatment of corticosteroids is needed. Thus, the investigators plan to conduct a phase II clinical trial to evaluate the efficacy and safety of toripalimab (PD-1 antibody) combined with the FLOAP (albumin-bound paclitaxel, oxaliplatin, fluorouracil and leucovorin) regimen as the perioperative treatment of cT2-4 and/or N+ GC. The primary end point is pCR rate. The secondary end points include disease free survival(DFS), OS, ORR, R0 resection rate, incidence of adverse events(AE).
CONDITIONS
Official Title
PD-1 Blockade With JS001 Plus Neoadjuvant Chemotherapy for Gastric/Gastroesophageal Junction Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 79 years
- Confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy
- Disease stage cT3/4a Nx or T2 N1-3, M0 confirmed by endoscopic ultrasound and/or CT/MRI
- Availability of tumor tissue samples for biomarker testing
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate bone marrow and organ function including neutrophil count ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥9.0 g/L, total bilirubin ≤1.5× upper limit, ALT and AST ≤3× upper limit, coagulation times ≤1.5× upper limit, serum creatinine ≤1.5× upper limit, and creatinine clearance >50 ml/min
You will not qualify if you...
- Severe allergy to monoclonal antibodies or any component of toripalimab
- Preoperative diagnosis of squamous cell carcinoma or neuroendocrine tumor
- History or current other malignancies within 5 years
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA4 agents
- History of autoimmune disease (except stable autoimmune hypothyroidism or controlled type 1 diabetes)
- Recent immunostimulatory drug therapy within 4 weeks before enrollment
- Previous allogeneic bone marrow or solid organ transplantation
- Active infections including tuberculosis, hepatitis B, hepatitis C, or HIV
- Positive hepatitis B or C tests without viral suppression
- Serious neurological or mental illness such as dementia or seizures
- Peripheral neuropathy grade 2 or higher
- Pregnant or breastfeeding women
- Chronic bowel disease or short bowel syndrome
- Dihydropyrimidine dehydrogenase enzyme deficiency
- Major cardiovascular diseases including recent myocardial infarction, unstable arrhythmia, or advanced heart failure
- Coronary artery disease or congestive heart failure requiring stable medical management
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Shenzhen People's Hospital
Shenzhen, Guangdong, China, 518020
Actively Recruiting
2
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
W
Wan He, PhD
CONTACT
W
Wenwen Li, PhD
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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