Indexing hint: Clinical trial · 2026
Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial.
Xu et al. 2026BMC medicine
PMID 41749205PMC12964648DOI 10.1186/s12916-026-04740-zPUB-41749205
Trial · Interventional
RecruitingPhase 2Registry dataChina
1 trial · 1 ongoing
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
NCT0646191014 Jun 2024 to est. Dec 2027
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.
Experimental
Serplulimab Combined with Thymalfasin and SOX
Outcomes the sponsor listed as primary.
pathological Complete Response (pCR)
Time frame · from preoperative to 10 days postoperative
pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.
Major Pathological Response (MPR)
Time frame · from preoperative to 10 days postoperative
For patients with surgically resectable gastric cancer after neoadjuvant therapy, the proportion of patients with less than 10% residual tumor cells in the primary site.
Tumor Regression Grade (TRG)
Time frame · from preoperative to 10 days postoperative
It is intended to grade the pathological response of tumor after neoadjuvant therapy and generally divide the grade mainly according to the proportion of fibrosis and residual tumor in the tumor. In this study, Becker criteria are used to grade TGR as follows: TRG1a (no residual tumor), equivalent to pCR; TRG1b (\< 10% residual tumor); TRG2 (10% to 50% residual tumor); and TRG3 (\> 50% residual tumor).
Clinical downstaging rate (T and/or N downstaging)
Time frame · before surgery
ypT0 ratio, ypN0 ratio, and preoperative imaging clinical stage will be counted, respectively, to compare with baseline imaging clinical stage downstaging ratio
Objective Response Rate (ORR)
Time frame · before surgery
It refers to the proportion of patients whose tumor shrinks to a certain extent and remains for a certain period of time, including CR (Complete Response) and PR (Partial Response) cases. Objective tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).
Disease Control Rate (DCR)
Time frame · before surgery
It refers to the percentage of confirmed complete response (CR), partial response (PR) and stable disease (SD) cases among evaluable efficacy patients.
Disease-free Survival (DFS)
Time frame · 2 years after surgery
Disease-free survival refers to the time from the start of randomization to disease recurrence or death due to disease progression. DFS will be defined as the last date the patient is last confirmed to be disease-free survival if the patient does not experience disease progression during the study.
Overall Survival (OS)
Time frame · 2 years after surgery
Overall survival refers to the date from enrollment to death due to any cause.
R0 resection rate
Time frame · from preoperative to 10 days postoperative
R0 resection rate refers to the proportion of patients who complete R0 resection in surgically resectable patients after neoadjuvant therapy.
treatment-related adverse event (TRAE)
Time frame · from the start of neoadjuvant therapy to 30 days after surgery
incidence of treatment-related adverse event
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
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Indexing hint: Clinical trial · 2026
Xu et al. 2026BMC medicine
PMID 41749205PMC12964648DOI 10.1186/s12916-026-04740-zPUB-41749205
Who could join, as posted.
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