Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

Phase 2 Recruiting 102 enrolled Shanghai Jiao Tong University School of Medicine Changshu Affiliated Hospital of Soochow University · collab Lanzhou University Second Hospital · collab Qilu Hospital of Shandong University · collab Qinghai People's Hospital · collab RenJi Hospital · collab Ruijin Hospital · collab Shanghai East Hospital of Tongji University · collab Shanghai Zhongshan Hospital · collab The Affiliated Hospital of Inner Mongolia Medical University · collab The First Affiliated Hospital of Anhui Medical University · collab The First People's Hospital of Nantong · collab The Second People's Hospital of Baoshan, Yunnan Province · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with GEMOX in recectable gallbladder carcinoma patients monitored by ctDNA.

Timeline

Start: 2020-06-01
Primary completion: 2025-06
Completion: 2025-12

Publications

Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	40 mg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	100 mg/m2	Intravenous

Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

Summary

Timeline

Publications

Drugs

Indications