stomach adenocarcinoma and esophageal squamous cell carcinoma
Conditions
Interventions
stomach adenocarcinoma group:PD-1 inhibitor and apatinib
esophageal squamous cell carcinoma group:PD-1 inhibitor and anlotinib
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study. 2) Male or female, aged >=18 years and = 90g / L; ANC >=1.5 x 10^9 /L; platelet >= 90 x 10^9 /L (patients have not received blood transfusion or growth factor support within 2 weeks prior blood collection). 8) Appropriate liver function is shown to meet all of the following requirements: a. Serum total bilirubin = 30g / L; c. AST, ALT = 50ml/min (using Cockcroft-Gault formula); b. Proteinuria = ++, 24-hour urine protein must be < 2g. 10) INR or prothrombin time (PT) <= 1.5 x ULN, APTT <= 1.5 x ULN; no history of anticoagulant treatment; investigator judges no high coagulation risk. 11) All acute toxic effects of previous anti-cancer treatment or surgery were all relieved by NCI-CTCAE version 5.0 <= 1 (except for hair loss or other toxic effects that the investigator judges to have no risk to the patient's safety). 12) Fertile women must have a negative urine or serum pregnancy test within 7 days before enrollment, and must agree to use effective contraception during the study period and within 6 months after the end of the study period; non-sterile men must agree to use efficient contraception during the study period and within 6 months after the study was completed. Patient agrees to avoid sperm donation during the same time period. 13) Have the ability to act autonomously, have the ability to swallow pills, and have no gastrointestinal diseases that affect oral drug absorption. 14) Agree to provide hematology and histology samples.
Exclusion criteria
Exclusion criteria: 1) Have undifferentiated or other histological types of gastric or esophageal cancer; evidence of tumor invasion of major blood vessels (including completely adjacent, surrounding, or extending into the main vessel lumen, such as the pulmonary artery or superior vena cava) , and the researcher judges that it is not suitable for enrollment. 2) Patients with active autoimmune disease or a history of autoimmune disease but who may relapse. Note: Patients with the following diseases are not excluded and can be entered for further screening: a. Controlled Type 1 Diabetes; b. Hypothyroidism (if only controlled by hormone replacement therapy); c. Controlled celiac disease; d. Skin diseases that do not require systemic treatment (e.g. vitiligo, psoriasis, hair loss); e. Any other disease that is not expected to recur without external triggers. 3) Any active malignant tumor within 2 years, except for the specific cancer being studied in this trial and cured local recurrent cancer (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ). 4) There is uncontrollable pleural effusion, pericardial effusion, or ascites that need to be drained frequently within 7 days before enrollment (allow effusion cytology to confirm). 5) Patients with gastrointestinal bleeding within two weeks before enrollment, or those at high risk of bleeding as judged by the investigator (Note: fecal occult blood (+) is not an exclusion criterion). 6) Gastrointestinal perforation and / or fistula occurred within 6 months before enrollment. 7) There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers. 8) Weight loss >= 20% within 2 months before enrollment. 9) History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable systemic diseases including diabetes, hypertension, pulmonary fibrosis, acute lung disease, etc. 10) Severe chronic or active infections, including tuberculosis, that require systemic antibacterial, antifungal or antiviral treatment. 11) Known history of HIV infection. 12) Patients with untreated chronic hepatitis B or chronic HBV carriers with hepatitis B virus (HBV) DNA exceeding ULN, or hepatitis C virus (HCV) RNA positive should be excluded. Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable patients with hepatitis B (HBV DNA = 2 occurred within <= 6 months before enrollment. f. Cerebrovascular accident (CVA) occurred within <= 6 months before enrollment g. Those with high blood pressure who cannot be controlled well with antihypertensive medications. The symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate;T cell receptor repertoire sequencing information; | — |
Countries
China
Contacts
Public ContactCui Yuehong
Zhongshan Hospital, Fudan University
Outcome results
None listed