About this trial
To evaluate the effectiveness and safety of SHR-A1811 combined with apatinib in the treatment of advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants voluntarily enrolled in this study and signed an informed consent form, were compliant and co-operated with follow-up visits;
Age 18-75 years, including 18 and 75 year, male and female;
ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
Has a life expectancy of greater than 3 months;
Disqualifiers
Patients with meningeal metastases; Or patients with brain metastases that have not been treated with surgery or radiation, but those who have been stable for at least one month after treatment and have stopped using steroid drugs (such as 10mg/day prednisone or other equivalent hormones) for more than 2 weeks except;
Uncontrolled pleural effusion or ascites;
There are serious concomitant diseases: such as serious cardiovascular and cerebrovascular disease, kidney failure, liver failure, hematopoietic disease, endocrine disease, cachexia, etc;
Previously received antibody drug conjugate therapy containing topoisomerase I inhibitors, such as trastuzumab deruxtecan (DS-8201), etc; Subjects underwent surgery (except diagnostic surgery), radiotherapy, chemotherapy, macromolecular targeted therapy or immunotherapy within 4 weeks before the first dose of the study drug;Small molecule targeted drugs (including other oral targeted drugs used in clinical trials) whose last dose is less than 5 half-life period or 4 weeks (whichever is shorter) from the first dose; Subjects received palliative radiotherapy or local treatment less than 2 weeks after completion of treatment and before the first dose;
Trial design
Parallel
Treatments tested in this trial
SHR-A1811 & Apartinib
DrugSHR-A1811 injection will be administered by intravenous infusion. And apatinib will be administered orally.
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate (ORR)
To evaluate the efficacy of anti-tumor
Secondary outcomes
Duration of Response (DOR)
To evaluate the efficacy of anti-tumor
Disease control rate (DCR)
To evaluate the efficacy of anti-tumor
Progression-free survival (PFS)
To evaluate the efficacy of anti-tumor
Overall survival (OS)
To evaluate the efficacy of anti-tumor
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yunpeng Liu
Lead sponsor
China Medical University, China
Sponsor institution
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options: