Last updated 16 days ago
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
550 patients around the world
Available in Chile, United States
In experimental group: HLX22 (15 mg/kg) + trastuzumab + chemotherapy (XELOX) ± placebo
(for pembrolizumab), once every 3 weeks (Q3W).
In control group: Placebo (for HLX22) + trastuzumab + chemotherapy (XELOX) ±
pembrolizumab, Q3W.
Shanghai Henlius Biotech
2Research sites
550Patients around the world
This study is for people with
Gastroesophageal cancer
Gastroesophageal adenocarcinoma
Gastric cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Male/female who are at least 18 years of age on the day of signing the informed consent.With histologically or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.Had measurable disease as assessed by IRRC according to the RECIST v1.1, the target lesion must not be a bone metastatic lesion only.HER2-positive tumor defined as either IHC 3+ or IHC 2+ in combination with ISH+ or FISH, as assessed by a central laboratory on a primary or metastatic tumor.ECOG PS within 7 days before randomization: 0-1.Expected survival ≥ 6 months.Had adequate organ function.
- Patients with other malignant tumors within 2 years before the randomization.Evidence of disease progression within 6 months before randomization after completion of prior neoadjuvant or adjuvant chemotherapy or radiotherapy for gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.Previous treatment with any HER2-target therapy.Active gastrointestinal bleeding.Presence of central nervous system metastases.Left ventricular ejection fraction (LVEF) < 55%.Subjects who had known history of severe allergy to any monoclonal antibody or any component of study treatment.
Sites
Centro de Oncología de Precisión
Recruiting
Clínica RedSalud Vitacura
Recruiting
SponsorShanghai Henlius Biotech
Study typeInterventional
Conditions
Gastroesophageal adenocarcinomaGastric cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06532006
