Adenocarcinoma of the stomach or gastroesophageal junction
Conditions
Interventions
Sponsors
The First Affiliated Hospital of USTC
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Male or female patients, aged 18-75 years old; 2.Advanced or metastatic gastric or gastroesophageal junction adenocarcinoma diagnosed by histopathology or cytology; 3.Patients with advanced gastric cancer who have failed first-line systemic treatment in the past (definition of treatment failure: intolerable side effects, disease progression during treatment or relapse after treatment); Note: (1)Treatment of each line of advanced disease Including one or more drugs with medication time 1>= cycle; (2)Early adjuvant/neo-adjuvant therapy is allowed. If recurrence occurs during adjuvant/neoadjuvant therapy or within = 12 weeks; 7.The main organs are functioning well; 8.The damage caused by the patient receiving other anti-tumor treatments has basically returned to normal (NCI-CTCAE = 6 weeks; receiving other cytotoxic drugs, radiotherapy or surgery >= 4 weeks, and the wound has healed completely; 9.Non-surgically sterilized female subjects of childbearing age must have a negative serum HCG test before enrollment; 10.Volunteer to join the study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of allergy to any study drug, similar drugs or excipients; 2.Previously received anti-vascular targeted therapy, such as ramucirumab and apatinib; 3.Uncontrollable moderate to large amounts of pleural effusion, abdominal effusion or pericardial effusion that require repeated drainage; 4.Patients with partial or complete gastrointestinal obstruction; 5.Suffer from high blood pressure and cannot be controlled; 6.Have clinical symptoms or diseases of the heart that are not well controlled; 7.There were clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; gastrointestinal perforation or gastrointestinal fistula occurred within 6 months before enrollment; 8.Long-term use of antiplatelet drugs such as aspirin and clopidogrel, or anticoagulant drugs such as warfarin; 9.Patients who have received treatment before, but less than 4 weeks after the completion of treatment (last medication) before enrollment; 10.At the same time receive any other anti-tumor treatments, including anti-tumor Chinese patent medicines and immune preparations; 11.According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); 12.Patients with unhealed wounds, unhealed ulcers or unhealed fractures; 13.Suffered from other nausea tumors in the past 3 years or at the same time; 14.The previously received treatment has residual toxicity (for example, blood system, cardiovascular system or neurotoxicity of grade >= 2), and hair loss is allowed; 15.The investigator judges other situations that are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Disease control rate;Remission of duration time;Overall survival;Adverse event (according to RECIST standard version 1.1); | — |
Countries
China
Contacts
Public ContactHe Yifu
The First Affiliated Hospital of USTC
Outcome results
None listed