Spots Global Cancer Trial Database for An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
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Trial Identification
Brief Title: An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma
Official Title: A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (MORPHEUS C-Gastric and Gastroesophageal Junction Carcinoma)
Study ID: NCT05251948
Study Description
Brief Summary: This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Cohort 1 will enroll participants with inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology, who have not received prior systemic therapy for advanced or metastatic disease. Eligible participants will initially be randomly assigned to one of treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The General Hospital of People?s Liberation Army (301 Hospital), Beijing City, , China
the First Hospital of Jilin University, Changchun, , China
First Affiliated Hospital of Gannan Medical University, Ganzhou, , China
The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China
The First Affiliated Hospital, Zhejiang University, Hangzhou City, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou City, , China
Harbin Medical University Cancer Hospital, Harbin, , China
The Second Affiliated Hospital of Anhui Medical University, Hefei, , China
Affiliated Hopsital of Jining Medical University, Jining, , China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Nanjing City, , China
Nan Tong Tumor Hospital, Nantong City, , China
Shanxi Province Cancer Hospital, Taiyuan City, , China
The First Affiliated Hospital of Xian Jiao Tong University, Xi'an City, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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