Spots Global Cancer Trial Database for DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

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Trial Identification

Brief Title: DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

Official Title: A Randomized，Multicenter, Open-Label，Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

Study ID: NCT06221748

Conditions

Gastric Cancer

Gastroesophageal Junction Adenocarcinoma

Interventions

Disitamab Vedotin Injection

Cadonilimab Injection

Paclitaxel Injection

Study Description

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.

Detailed Description: This is an open-label, randomized, multicenter, Phase II/III Study designed to evaluate safety and efficacy of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy. This clinical study was divided into two parts, phase II and III.Part I: Phase II study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus Disitamab Vedotin versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy. Part II: Phase III study primary objectives of the study are to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab versus paclitaxel in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy. Tumor assessments, including radiological assessments by CT/MRI scans will be performed at Screening and subsequently every 6 weeks (±7 days) until disease progression, death, the start of new anticancer therapy, or patient's withdrawal of consent (whichever occurs first). All patients who discontinue treatment will be followed for survival every 3 months until death, lost to follow-up, withdrawal of consent for survival follow-up, or end of study (whichever comes first).