Advanced gastric or gastroesophageal adenocarcinoma
Conditions
Interventions
1:Apatinib treatment
2:Camrelizumab treatment
3:Apatinib combined with Camrelizumab
Sponsors
Lanzhou University Second Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent; 2. Aged > 18 years; 3. Histologically confirmed unresectable advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; 4. ECOG score 0-2; expected survival time is more than 3 months 5. Measurable lesions according to RECIST standards; 6. The laboratory inspection within 14 days before entering the study must meet: (1) ANC >= 1.5 x 10^9/L; (2) Platelets >= 100 x10^9/L; (3) Hb >= 90 g/L (9 g/dL); (4) AST, ALT <= 2.5 ULN); (no evidence of liver metastasis); (5) AST, ALT <= 5.0 ULN (if there is evidence of liver metastasis); (6) Creatinine <= 1.5 ULN; (7) Total bilirubin <= 1.5 ULN; (8) International normalized ratio (INR) <= 1.5, prothrombin time (PT) and activation partial thromboplastin time (APT) <= 1.5 ULN; thyroid stimulating hormone (TSH) <= ULN; if abnormal, T3 and T4 levels should be examined, and T3 and T4 levels can be selected; 7. Female subjects of childbearing age must undergo serum pregnancy within 3 days prior to commencing study medication, Pregnancy test with negative results and willingness to use a medically approved and effective contraceptive (such as an intrauterine device, contraceptive or condom) during the study and within 3 months after the last study drug Male subjects who are women of childbearing age should be surgically sterilized or agree to use effective contraception during the study and within 3 months after the last study dose; 8. With my consent and signed informed consent, willing and able to comply with the plan visits, research treatments, laboratory tests and other test procedures.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received chemotherapy, radiotherapy, biotargeting and immunotherapy; 2. Severe active infection requiring intravenous antibiotics during enrollment; 3. Those who are allergic to the test drugs; 4. Patients with a clear tendency to gastrointestinal bleeding. Including the following conditions: (1) there are local active ulcer lesions, and fecal occult blood 2+; (2) patients with a history of melena and vomiting within 2 months; (3) those with occult blood 1+ and the primary tumor of the stomach have not undergone surgical resection Perform gastroscopy, such as ulcerative gastric cancer, and the center's main investigator believes that major gastrointestinal bleeding may occur; 5. Those who have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, etc.); 6. Patients with any severe and / or uncontrolled illness, including: A hypotensive drug is still not optimally controlled (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg); Patients with grade I or higher myocardial ischemia or myocardial infarction, malignant arrhythmias (including QTC >= 480ms), and grade 2 or higher congestive heart failure (NYHA classification); Cirrhosis, decompensated liver disease, active hepatitis; Renal failure requires hemodialysis or peritoneal dialysis); Have a history of immunodeficiency, including those who are HIV positive or have other acquired or congenital immunodeficiency disorders, or have a history of organ transplantation; Poor diabetes control (fasting blood glucose (FBG)> 10mmol / L); Urine routine indicates urinary protein >= ++, and the 24-hour urine protein quantification is greater than 1.0 g Patients with seizures who need treatment; Patients whose imaging has shown that the tumor has invaded the vital blood vessels or the investigator has judged that the tumor is likely to invade important blood vessels and cause fatal bleeding during subsequent studies; Patients with any signs or history of bleeding regardless of severity; patients with any bleeding or bleeding event >= CTCAE Grade 3 with unhealed wounds, ulcers, or fractures within 4 weeks prior to grouping; Grade 1 Neuropathy (CTC AE 4.0); People with ineffectively controlled, symptomatic brain metastases, or a history of uncontrollable mental illness; severe intellectual or cognitive dysfunction; Exclude subjects with active, known or suspected autoimmune disease. Patients have type I diabetes, hypothyroidism who only needs hormone replacement therapy, skin disorders that do not require systemic treatment sites (eg, vitiligo, psoriasis, or hair loss), or are expected to be in a state without external trigger Reproducible subjects can be admitted to the hospital; Have previously been treated with anti-tumor vaccines or other anti-tumor drugs with immunostimulatory effects. Subjects in need of systemic corticosteroids or other immunosuppressive drugs within 14 days prior to randomization. Observation of target lesions with curative effect and concurrent radiotherapy; Patients the investigator considers inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS; | — |
Countries
China
Contacts
Public ContactChen Hao
Lanzhou University Second Hospital
Outcome results
None listed