Analyzing PD-1 Blockades and Chemotherapy for Advanced Gastric Cancer
The Comparison of Different Cycles of PD-1 Blockades Combined with Chemotherapy As Neoadjuvant Therapy for Patients with Advanced Gastric Cancer
This study is testing how different lengths of a new cancer treatment combining PD-1 inhibitors and chemotherapy can help people with advanced stomach cancer and how safe it is before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06798376 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effects of different durations of neoadjuvant PD-1 inhibitor therapy combined with chemotherapy on tumor regression and safety in patients with advanced gastric adenocarcinoma. It will analyze clinical data from patients who have undergone this treatment followed by surgery, focusing on how treatment duration influences tumor regression grading and perioperative outcomes. The study will utilize retrospective data analysis to draw conclusions about the effectiveness and safety of the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates include non-bedridden adults aged 18-90 with histologically confirmed resectable advanced gastric or gastroesophageal junction adenocarcinoma who have received neoadjuvant PD-1 inhibitors and chemotherapy.
Not a fit: Patients with distant metastases, incomplete clinical data, or those with concurrent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing neoadjuvant treatment strategies for advanced gastric cancer, potentially improving patient outcomes.
How similar studies have performed: While this approach is based on existing treatments, the specific analysis of treatment duration in this context may provide novel insights, as similar studies have shown varying results with neoadjuvant therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Non-bedridden patients aged 18-90 years; * Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy; * Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration; * No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy; * No history of other malignancies within the past 5 years; * Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents; * Underwent radical gastrectomy after neoadjuvant therapy; * No severe underlying diseases. Exclusion Criteria: * Incomplete or inaccessible clinical and pathological data; * Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma; * Distant metastases present prior to treatment; * Concurrent diagnosis of other malignancies.
Where this trial is running
Beijing
- Chinese PLA General Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Xinxin Wang
- Email: wangxx301@outlook.com
- Phone: +86-15022709006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.