Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemo-immunotherapy | Drug | Pucotenlimab combined with chemotherapy (Nab-Paclitaxel + Tegafur + Carboplatin) |
|
| Measure | Description | Time Frame |
|---|---|---|
| pCR | Pathological complete response rate | From enrollment to the end of treatment at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of treatment at 2 weeks |
Inclusion Criteria:
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.
cTNM staging of cT2N+M0 or cT3-4bNxM0 based on endoscopic ultrasonography, contrast-enhanced CT/MRI (with endoscopic ultrasonography, diagnostic laparoscopy, or PET-CT as needed), corresponding to locally advanced gastroesophageal junction tumor per AJCC 9th edition, and deemed resectable by the investigator.
Prior Treatment History No prior systemic therapy for the current disease, including surgery, anti-tumor radiotherapy/chemotherapy, immunotherapy, etc.
Surgical Eligibility Agree to receive radical surgery and have no surgical contraindications as judged by surgeons.
Target Lesion Assessment At least one lesion (untreated with radiotherapy) meets RECIST 1.1 target lesion (TL) criteria.
Tumor assessment must be performed via CT or MRI within 28 days before treatment.
Performance Status ECOG score of 0-1.
Life Expectancy Expected survival ≥ 3 months.
Organ Function Requirements
Laboratory parameters must meet the following within 14 days:
Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L (without granulocyte colony-stimulating factor use).
Platelets ≥ 100×10⁹/L (without blood transfusion). Hemoglobin > 9 g/dL (without blood transfusion or erythropoietin use). Total bilirubin ≤ 1.5×ULN; if total bilirubin > 1.5×ULN, direct bilirubin must be ≤ ULN.
AST and ALT ≤ 2.5×ULN. Serum creatinine ≤ 1.5×ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 60 mL/min.
Coagulation function: INR or PT ≤ 1.5×ULN. No severe thyroid dysfunction (as judged by the investigator). Cardiac function: NYHA class < 3; left ventricular ejection fraction ≥ 50%. 10. Contraceptive Measures and Pregnancy Testing
For female subjects of childbearing potential:
Negative urine or serum pregnancy test within 3 days before the first study drug administration (Cycle 1, Day 1). If urine test is inconclusive, a blood test is required.
Non-childbearing potential is defined as postmenopausal for ≥1 year, surgically sterilized, or having undergone hysterectomy.
All subjects (male and female) at risk of conception must use contraception with an annual failure rate < 1% throughout treatment and for 120 days after the last study drug administration (or 180 days after the last chemotherapy dose).
Exclusion Criteria:
Note: Hepatitis B subjects meeting the following criteria can also be enrolled:
1) HBV viral load < 1000 copies/ml (200 IU/ml) before the first administration, and subjects should receive anti-HBV treatment during the entire study period of chemotherapeutic drug treatment to avoid viral reactivation; 14. Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the lower limit of detection); 15. Having received a live vaccine within 30 days before the first administration (Cycle 1, Day 1); Note: Administration of inactivated viral vaccines for seasonal influenza within 30 days before the first administration is allowed; however, intranasal attenuated live influenza vaccines are not allowed; 16. Pregnant or lactating women; 17. Having any severe or uncontrollable systemic diseases, such as:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan | Contact | +8615991269383 | yanxiaolong@fmmu.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From enrollment to the end of treatment at 3 years |
| R0 resection rate |
Achievement of a curative resection rate of all surgery |
| From enrollment to the end of treatment at 2 weeks |
| overall survival | The time from randomization to the patient's death from any cause | From enrollment to the end of treatment at 5 years |
| 3-year OS | Patients from randomization to the patient's death from any cause at 3 year rate in all patients | From enrollment to the end of treatment at 3 years |
| Progression-free Survival | The time between the start of randomization and the occurrence of tumor progression (in any aspect) or death (due to any reason) | From enrollment to the end of treatment at 5 years |
| 3-year PFS | Patients from randomization to the patient's occurrence of tumor progressionrom any cause at 3 year rate in all patients | From enrollment to the end of treatment at 3 years |
| Adverse Event | Adverse medical events experienced by subjects during the clinical trial process | From enrollment to the end of treatment at 5 years |