This study is a prospective, multicenter, single-arm clinical trial.
The study intends to enroll patients with pathologically or cytologically confirmed resectable locally advanced gastroesophageal junction tumors (cT2N+M0 and cT3-4bNxM0) who have not received prior systemic therapy. After signing the informed consent and being screened to meet the inclusion and exclusion criteria, patients will receive 3 cycles of Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin). Preoperative imaging evaluations will be performed 3 to 6 weeks after the final dose administration to assess the efficacy of neoadjuvant therapy and the feasibility of radical resection. Efficacy evaluation will be performed after radical surgery for locally advanced gastroesophageal junction tumors.
Informed Consent Provide written informed consent for the clinical study and biobank before any study-related procedures.
Age and Gender Male or female patients aged 18 to 75 years.
Disease Diagnosis Histologically confirmed resectable locally advanced gastroesophageal junction tumor.
Prior Treatment History No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
Diagnosed with malignant diseases other than gastroesophageal junction tumors within 5 years before the first administration (excluding radically treated basal cell carcinoma of the skin, cutaneous squamous cell carcinoma, and/or carcinoma in situ after radical resection);
Known endoscopic evidence of active bleeding in the lesion;
Known evidence of distant metastasis;
Currently participating in therapeutic interventions of an interventional clinical study, or having received other drug therapies for malignant gastroesophageal junction tumors within 4 weeks before the first administration;
Single group
Neoadjuvant chemo-immunotherapy
DrugPucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin)
pCR
Pathological complete response rate
Major pathological response (MPR) Objective response rate (ORR) R0 resection rate Overall survival (OS) and 3-year overall survival rate (3-year OS) Disease-free survival (DFS) and 3-year disease-free survival rate (3-year DFS) Adverse events (AEs)
Major pathological response (MPR) Objective response rate (ORR) R0 resection rate Overall survival (OS) and 3-year overall survival rate (3-year OS) Disease-free survival (DFS) and 3-year disease-free survival rate (3-year DFS) Adverse events (AEs)
Objective response rate（ORR)
The proportion of patients whose tumor volume shrinks to a predefined value and can maintain this minimum threshold for a required minimum duration is the sum of the proportions of complete response (CR) and partial response (PR). ORR = CR + PR
R0 resection rate
Achievement of a curative resection rate of all surgery
overall survival
The time from randomization to the patient's death from any cause
3-year OS
Patients from randomization to the patient's death from any cause at 3 year rate in all patients
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This trial is not recruiting at the moment. You can still explore other options:
