Gastroesophageal Junction Adenocarcinoma, Gastric Adenocarcinoma
Conditions
Brief summary
This is a single-center, prospective, exploratory clinical study. Eligible patients will be enrolled and receive iapalolimab combined with DOS regimen (docetaxel + oxaliplatin + tegafur-gimeracil-oteracil potassium). The study aims to further explore the efficacy and safety of iapalolimab plus DOS regimen for locally advanced gastric or gastroesophageal junction adenocarcinoma. A total of 34 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma will be enrolled. Each treatment cycle lasts 21 days. After 3-4 cycles, patients who are assessed as operable by investigators will undergo surgical resection, and postoperative pathological results will be evaluated. The primary outcome measure is the pathological complete response rate. Investigators will determine subsequent treatment regimens based on patients' pathological findings and routine clinical practice at the study center. Radiological assessment of tumor response is recommended every 2 cycles.
Interventions
5 mg/kg intravenous infusion on Day 1 every 3 weeks.
DRUGS-1
40 mg/m² orally twice daily on Day 1-14 every 3 weeks.
DRUGOxaliplatin
100 mg/m² intravenous infusion on Day 1 every 3 weeks.
DRUGDocetaxel
40 mg/m² intravenous infusion on Day 1 every 3 weeks.
Sponsors
Yongxu Jia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Participants, investigators and all study personnel are aware of the intervention administered.
Intervention model description
All eligible participants will receive the same investigational intervention without a control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-75 years old, male or female; * Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction; * Clinical stage cT3-4a/N+M0; * ECOG performance status 0-1; * Adequate function of major organs assessed within 7 days before treatment: 1. Hematological indicators (without blood transfusion within 14 days): Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L; 2. Biochemical indicators: Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 ml/min; 3. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); 4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; * Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment; * Subjects voluntarily participate in this study and sign written informed consent.
Exclusion criteria
* Inclusion Criteria: * Aged 18-75 years old, male or female; * Previously untreated, surgically resectable adenocarcinoma of the stomach or gastroesophageal junction; * Clinical stage cT3-4a/N+M0; * ECOG performance status 0-1; * Adequate function of major organs assessed within 7 days before treatment: 1. Hematological indicators (without blood transfusion within 14 days): Hemoglobin (HB) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L; 2. Biochemical indicators: Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 ml/min; 3. Assessed by Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%); 4. Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; * Subjects of childbearing potential agree to use effective contraception during the study and for 6 months after the end of study treatment; * Subjects voluntarily participate in this study and sign written informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) rate | Up to 24 weeks after completion of neoadjuvant therapy and surgical resection | Pathological complete response (pCR) is defined as no residual tumor cells identified in the primary tumor bed and regional lymph nodes after surgical resection, which means complete pathological regression of the tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 Resection Rate | Up to 24 weeks after completion of neoadjuvant therapy and gastrectomy. | R0 resection is defined as complete resection of the tumor lesion. No residual tumor is visible macroscopically, and no tumor cells can be identified microscopically at the resection margins without any residual tumor components, achieving radical surgical effect. The R0 resection rate refers to the proportion of patients who achieve R0 resection. |
| Objective Response Rate | Up to 12 weeks after completion of neoadjuvant therapy, prior to gastrectomy. | Objective Response Rate (ORR) is defined as the proportion of subjects achieving confirmed complete response (CR) plus partial response (PR) as assessed per RECIST version 1.1 |
| Major Pathological Response (MPR) Rate | Up to 24 weeks after completion of neoadjuvant therapy and gastrectomy. | Major pathological response (MPR) is defined as ≤10% viable residual tumor cells both in the primary tumor bed and regional lymph nodes after gastrectomy. The MPR rate refers to the proportion of subjects achieving MPR after gastrectomy. |
| Disease Control Rate | Up to 12 weeks after completion of neoadjuvant therapy, prior to gastrectomy | Disease Control Rate (DCR) is defined as the proportion of subjects achieving confirmed stable disease (SD), partial response (PR), and complete response (CR) as assessed per RECIST version 1.1. |
| Incidence of Adverse Events | From the start of neoadjuvant therapy until 30 days after gastrectomy. | Safety will be evaluated by monitoring the incidence, type, severity, and relatedness of adverse events (AEs) and serious adverse events (SAEs) according to CTCAE. Assessments include physical examinations, routine laboratory tests, and continuous adverse event collection. |
| 3-year Disease-Free Survival (DFS) Rate | From the date of gastrectomy until 3 years after gastrectomy. | Disease-free survival (DFS) is defined as the time from the date of randomization to the first documented disease recurrence (local recurrence, regional recurrence or distant metastasis) or death from any cause, whichever occurs first. The 3-year DFS rate is the proportion of subjects who remain alive without disease recurrence at 3 years after randomization. Time Frame: From the date of randomization until 3 years after randomization |
Countries
China
Outcome results
None listed