The Efficacy and Safety of Anti-PD-1 Combined With Thymalfasin and SOX in Neoadjuvant Treatment of cStage III Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Open-label, Single-arm, Phase II Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Serplulimab
- Conditions
- Gastric Cancer
- Sponsor
- Zekuan Xu
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- pathological Complete Response (pCR)
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.
Detailed Description
This is a prospective, open-label, single-arm phase II clinical study to assess the efficacy and safety of Serplulimab in combination with thymalfasin and SOX regimen for neoadjuvant therapy of locally advanced gastric cancer. It is planned to enroll 30 patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology who were clinically staged as stage III resectable G/GEJ carcinoma as assessed by endoscopic ultrasonography, CT/MRI and other imaging. The primary endpoint of the study was pathological complete response (pCR) rate. The secondary end points included major pathological response(MPR) rate, Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR), R0 resection rate, Disease-free Survival (DFS), Overall Survival (OS) and treatment-related adverse events (TRAEs).
Investigators
Zekuan Xu
Professor
The First Affiliated Hospital with Nanjing Medical University
Eligibility Criteria
Inclusion Criteria
- •Age and Diagnosis:
- •Patients aged 18-75 years with gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma, regardless of gender.
- •Stage and Diagnosis Confirmation:
- •According to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0).
- •Diagnosis must be confirmed by endoscopy and pathology as G/GEJ adenocarcinoma (HER-2 negative).
- •Only patients with Siewert type III and type II (who do not require combined thoracic surgery) GEJ cancer are eligible.
- •Surgical Assessment:
- •Tumors must be deemed resectable with curative intent (R0 resection) as determined by a gastrointestinal surgeon and a radiologist.
- •Patients must agree to undergo radical surgery and be deemed operable by a surgeon.
- •Previous Treatments:
Exclusion Criteria
- •Other Malignancies:
- •Patients with a history of other malignancies within the past 5 years or concurrent malignancies. Exceptions include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, and stage I colorectal cancer.
- •Transplant Patients:
- •Patients planning to undergo or having previously undergone organ or bone marrow transplantation.
- •Blood Transfusions and Bleeding:
- •Patients who have received a blood transfusion within 2 weeks before the first dose, have a history of bleeding, or experienced any severe bleeding events (grade 3 or higher per CTCAE 4.0) within 4 weeks before screening.
- •Coagulation Disorders:
- •Patients with coagulation abnormalities and bleeding tendencies (INR \> 1.5 without anticoagulants). Patients on anticoagulants or vitamin K antagonists like warfarin, heparin, or similar drugs can participate if INR ≤ 1.5, small-dose warfarin (1 mg/day) or aspirin (≤ 100 mg/day) is allowed for preventive use.
- •Thromboembolic Events:
- •Patients with arterial/venous thromboembolic events within 6 months before screening, such as stroke (including transient ischemic attacks), deep vein thrombosis (excluding cases resolved post-chemotherapy), and pulmonary embolism.
Arms & Interventions
Serplulimab Combined with Thymalfasin and SOX
Intervention: Serplulimab
Serplulimab Combined with Thymalfasin and SOX
Intervention: thymalfasin
Serplulimab Combined with Thymalfasin and SOX
Intervention: Oxaliplatin
Serplulimab Combined with Thymalfasin and SOX
Intervention: Tegafur
Outcomes
Primary Outcomes
pathological Complete Response (pCR)
Time Frame: from preoperative to 10 days postoperative
pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.
Secondary Outcomes
- treatment-related adverse event (TRAE)(from the start of neoadjuvant therapy to 30 days after surgery)
- Major Pathological Response (MPR)(from preoperative to 10 days postoperative)
- Tumor Regression Grade (TRG)(from preoperative to 10 days postoperative)
- Clinical downstaging rate (T and/or N downstaging)(before surgery)
- Objective Response Rate (ORR)(before surgery)
- Disease Control Rate (DCR)(before surgery)
- Disease-free Survival (DFS)(2 years after surgery)
- Overall Survival (OS)(2 years after surgery)
- R0 resection rate(from preoperative to 10 days postoperative)