Locally advanced lung cancer (LALC) has poor prognosis despite multimodal therapies. Neoadjuvant chemoimmunotherapy is now standard for resectable stage II-IIIB NSCLC, but patient responses vary. The gut microbiota, a key immune regulator, has been linked to immunotherapy efficacy, with microbial diversity predicting ICI response and fecal microbiota transplantation improving outcomes. While most studies focus on advanced disease, the microbiota's role in LALC during neoadjuvant therapy remains unclear. Exploring its dynamics may uncover novel biomarkers and strategies to optimize treatment
Study Type
OBSERVATIONAL
Enrollment
100
neoadjuvant chemoimmunotherapy typically involves a PD-1 inhibitor-such as nivolumab, sintilimab, or camrelizumab-combined with platinum-based doublet chemotherapy (e.g., paclitaxel plus cisplatin for squamous cell carcinoma, or pemetrexed plus cisplatin for adenocarcinoma). The standard regimen includes three treatment cycles administered every three weeks, followed by surgical resection within 4-6 weeks. Some patients may receive up to one year of adjuvant immunotherapy postoperatively.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Pathologic complete response (pCR)
Pathological complete response (pCR) is defined as the absence of any residual invasive cancer in the resected primary tumor and lymph nodes following neoadjuvant therapy, as assessed by histopathological examination
Time frame: From surgery to the end of the 1-month postoperative (periodPerioperative/Periprocedural)
Major pathological response (MPR)
Major pathological response (MPR) is defined as ≤10% residual viable tumor cells in the resected primary tumor specimen after neoadjuvant therapy, as determined by histopathological evaluation
Time frame: From surgery to the end of the 1-month postoperative (periodPerioperative/Periprocedural)
Radiological response
Defined as radiographic change assesed by RECIST 1.1
Time frame: From the time of enrollment through the completion of surgery(Perioperative/Periprocedural)
Immune-related adverse event (irAE)
defined as all levels of adverse drug reactions in antitumor immunotherapy that are judged to be related to immune mechanisms, excluding non-specific infusion reactions
Time frame: From the time of enrollment through the completion of surgery(Perioperative/Periprocedural)
gut microbiomes
Defined as microbial composition, diversity, and functional activity measured by metagenomic sequencing
Time frame: From the time of enrollment through the completion of surgery(Perioperative/Periprocedural)
Disease free survival (DFS)
Defined as the time from the date of definitive treatment (e.g., surgery) until the date of recurrence of cancer, the occurrence of a second primary cancer, or death from any cause, whichever occurs first.
Time frame: From the postoperative period through 1 year after surgery
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