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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Phase II and III study :2.5mg/kg, intravenous infusion,D1, every 2 weeks
Phase II and III study :6.0mg/kg, intravenous infusion,D1, every 2 weeks.
Phase II and III study :Calculate dosage based on body surface are,160mg/m2,intravenous infusion,D1,D8 every 3 weeks
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Objective remission rate (ORR) (Phase II)
ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Time frame: Up to approximately 2 years
Percentage of Participants With Adverse Events (AEs)(Phase II)
Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE v5.0
Time frame: Up to approximately 2 years
Progression-Free Survival(PFS) (IRC)( Phase III)
PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)
Time frame: Up to approximately 2 years
Overall Survival (OS)(Phase III)
OS was defined as the time from the date of randomization to the date of death from any cause.
Time frame: Up to approximately 2 years
Progression-Free Survival(PFS)(investigator)(Phase II and Phase III)
PFS was defined as the time from random assignment to the onset of disease progression (as assessed by the IRC according to RECIST v1.1 criteria) or death (whichever event occurs first)
Time frame: Up to approximately 2 years
Overall Survival (OS)(Phase II)
OS was defined as the time from the date of randomization to the date of death from any cause.
Time frame: Up to approximately 2 years
Objective remission rate (ORR) (investigator) (Phase III)
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGHubei Cancer Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGXuzhou Central Hospital
Xuzhou, Jiangsu, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
RECRUITINGThe Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
NOT_YET_RECRUITINGRuijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
NOT_YET_RECRUITING...and 2 more locations
ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Time frame: Up to approximately 2 years
Disease Control Rate (DCR) (Phase II and Phase III)
Percentage of patients with complete response, partial response, or stable disease for a certain period of time according to RECIST v1.1.
Time frame: Until progression, assessed up to approximately 2 years
Duration of response (DoR) (Phase II and Phase III)
Defined as the time from the date of first documented response (CR/PR) until the first progression or death in the absence of disease progression by Investigators assessment according to RECIST 1.1
Time frame: Until progression, assessed up to approximately 2 years
Type, incidence, relatedness, severity, and seriousness of AEs
According to NCI-CTCAE Version 5.0 per each treatment arm
Time frame: Up to approximately 2 years
Incidence of laboratory tests abnormalities
To be summarized using descriptive statistics
Time frame: Up to follow-up period, approximately 2 years
Incidence of ECG abnormalities
To be summarized using descriptive statistics
Time frame: Up to follow-up period, approximately 2 years
Incidence of echocardiograms abnormalities
Change from baseline of LVEF
Time frame: Up to approximately 2 years