Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT07194005
Brief Summary:
This study aims to evaluate the efficacy of disitamab vedotin in combination with sintilimab and SOX as conversion therapy in patients with initially unresectable locally advanced or metastatic gastric cancer exhibiting HER2 IHC 1+/2+ expression. The trial plans to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ status. Participants will receive disitamab vedotin combined with sintilimab and SOX for 4 to 6 treatment cycles. Those who achieve successful conversion will undergo surgical resection, while patients with unsuccessful conversion will either continue the original regimen or switch to an alternative treatment at the investigator's discretion.
Detailed Description:
This is an open-label, single-arm, exploratory study designed to enroll patients with a single initial unresectable factor and HER2 IHC 1+/2+ locally advanced or metastatic gastric cancer. The primary objective is to assess the efficacy of the combination regimen based on the R0 resection rate. Tumor response will be evaluated every 6 to 12 weeks via imaging to determine whether surgical criteria are met. Patients who meet the criteria for operability will proceed to surgery, and postoperative adjuvant therapy will be tailored by the investigator based on individual patient conditions. For those who do not achieve successful conversion, the investigator will decide whether to continue the original treatment or transition to an alternative therapeutic strategy.
Study:
NCT07194005
Study Brief:
Protocol Section:
NCT07194005