Gastric (Stomach) Cancer
Conditions
Keywords
Gastric Cancer, HER2-Negative, Objective response rate
Brief summary
The purpose of this study is to evaluate the objective response rate (ORR) of Pembrolizumab combined with Lenvatinib and SOX compared with SOX alone in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.
Detailed description
At present, for patients with advanced gastric cancer, palliative chemotherapy or the best supportive care is the main treatment approach, but the therapeutic effect is not satisfactory. The median survival time is around 10-16 months, and the survival rate of patients is very low. How to improve the treatment effect of advanced gastric cancer is an urgent problem to be solved. Currently, several studies on immunotherapy combined with chemotherapy for gastric cancer are underway. From the subgroup analyses of a series of studies ，it can be seen that the expression of PDL1 is increased, which provides a basis for the treatment of advanced tumors with immune checkpoint inhibitors. Studies have shown that the combination of Lenvatinib can reduce angiogenesis in mice, reprogram vascular structure, enhance the infiltration of CD8+ T cells, CD8+ TNFα+ T cells and CD8+ IFNγ+ T cells, and decrease the proportion of MDSCs and macrophages. This provides a basis for the combined use of Lenvatinib and immune checkpoint inhibitors in the treatment of advanced tumors. This study adopts a single-center, prospective research method, aiming to explore the clinical effectiveness and safety of Pucotenlimab combined with Lenvatinib and the SOX regimen in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.
Interventions
Pucotenlimab Combined with Lenvatinib
DRUGOxaliplatin plus S-1 regimen
Oxaliplatin plus S-1 regimen
Sponsors
Fujian Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\*\*Inclusion Criteria\*\* 1. Age 18-75 years (inclusive). 2. Histologically or cytologically confirmed unresectable, locally advanced or metastatic HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction (GEJ). 3\. No prior systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy for advanced disease. Subjects who have received prior (neo)adjuvant chemotherapy and/or radiotherapy are eligible provided the last dose was completed ≥ 6 months before randomisation. 4\. At least one measurable lesion per RECIST 1.1 (see Appendix 2). 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 4). 6\. Estimated life expectancy \> 3 months. 7. Adequate major organ function defined as: 1. Haematology (obtained ≤ 14 days without transfusion): 1. Hb ≥ 80 g/L 2. WBC ≥ 3 × 10⁹/L 3. ANC ≥ 1.5 × 10⁹/L 4. PLT ≥ 100 × 10⁹/L 2. Biochemistry: 1. Total bilirubin \< 1.5 × upper limit of normal (ULN) 2. ALT and AST \< 2.5 × ULN; ALP ≤ 1.5 × ULN 3. Serum creatinine ≤ 1 × ULN and calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) 8. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrolment and must use highly effective contraception from screening until 8 weeks after the last dose of study drug. Men must be surgically sterile or agree to use effective contraception during the same period. 9\. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study. 10\. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 30day | Objective Response Rate (ORR) is defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) based on standardized, objective criteria (e.g., RECIST 1.1). |
| Objective Response Rate | 30day | This study uses the objective response rate (ORR) as the primary efficacy evaluation metric. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival | according to the OS | Median Overall Survival (OS) is defined as the time from the date of diagnosis or initiation of treatment to the point at which 50% of patients have died (or reached the study endpoint event), serving as a key indicator for evaluating treatment efficacy and prognosis in chronic diseases such as cancer. |
| Progression-Free Survival | 36 months | Progression-Free Survival (PFS) is defined as the time from randomization (or initiation of treatment) to the first documented disease progression (PD) or death from any cause, whichever occurs first |
| Duration of Response | 30day | Duration of Response (DOR) is defined as the time from the first documented complete response (CR) or partial response (PR) until disease progression (PD) or death from any cause, whichever occurs first. |
| Adverse Event | 30 days | Adverse Event (AE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event during a specified observation period after initiation of an intervention (drug, device, or procedure); it quantifies the frequency of intervention-related risk. |
| Serious Adverse Event | 30 days | erious Adverse Event (SAE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event meeting seriousness criteria during a specified observation period after initiation of an intervention; it quantifies intervention-related risks with potential for major medical consequences or death. |
| Quality of Life (QoL) assessment | 36 months | Quality of Life (QoL) assessment is the systematic collection of patients' subjective experience across multiple domains-including physical function, psychological state, social adaptation, and symptom burden-using validated, standardized patient-reported outcome (PRO) instruments; it quantifies the overall impact of disease and its treatment on patients' daily living and serves as a key endpoint in clinical research and therapeutic decision-making. |
Countries
China
Outcome results
None listed