Gastric Cancer Eesophageal Cancer
Conditions
Interventions
Group A:Raltitrexed Combined with Toripalimab and Anlotinib
Group B:Raltitrexed Combined with Toripalimab
Sponsors
Peking University International Hospital; The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) 18-75 years old, male or female patients; 2) Patients with advanced or metastatic esophageal and gastric cancer that cannot be surgically removed and confirmed by histopathology and / or cytology. Pathological types include squamous cell carcinoma, adenocarcinoma, and adenocarcinoma do not include neuroendocrine tumors. a) After the first-line standard treatment such as fluorouracil (5-fluorouracil, capecitabine, tegafur) or platinum (cisplatin, oxaliplatin), taxane and other single or two drug combination chemotherapy regimens failed People who cannot tolerate second-line chemotherapy; b) Patients who have failed second-line chemotherapy; c) At least 4 weeks from the end of the last chemotherapy; 3) Expected survival >= 3 months; 4) ECOG score 0-2 ; 5) At least one measurable objective tumor (RECIST 1.1), the maximum diameter of spiral CT must be >= 1cm, and the maximum diameter of ordinary CT or physical examination >= 2cm; 6) Laboratory inspection results within 1 week before enrollment meet the following conditions: neutrophil (ANC) >= 1.5 x 10^9 / L; platelet (PLT) >= 75 x 10^9 / L; hemoglobin (HGB) >= 80g / L; total bilirubin (TBI) = 50mL / min 7) Patients participate voluntarily and sign informed consent; 8) Urine pregnancy test result is negative (female), and effective contraceptives can be taken during the trial to 3 months after the end of the trial.
Exclusion criteria
Exclusion criteria: 1) Have previously received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody therapy, or any other antibody or target that specifically targets T cell co-stimulation or checkpoint pathways or drug. 2) People who are allergic to raltitrexed, anlotinib or PD1 antibody; 3) Patients with known dMMR / MSI-H; 4) Suffer from interstitial lung disease requiring steroid hormone treatment; 5) Have received systemic treatment of Chinese herbal medicines or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) with antitumor indications within 2 weeks before the first administration; 6) Have used immunosuppressive drugs within 1 week before the date of randomization, that is, more than 10 mg / day of prednisone or equivalent dose of other glucocorticoids, or use of hormones to prevent allergy to contrast agents; 7) Live attenuated vaccine within 4 weeks prior to the first dose of study treatment or planned during the study period; inactivated virus vaccine for seasonal influenza is allowed to be received within 4 weeks prior to the first dose; however, attenuation is not permitted Live flu vaccine; 8) Known active autoimmune disease and need symptomatic treatment or a history of the disease within the past 2 years (Vitiligo, psoriasis, hair loss or Grave's disease without systemic treatment in the last 2 years, only required Hypothyroidism in thyroid hormone replacement therapy and patients with type I diabetes who only require insulin replacement therapy can be included); 9) Known history of primary immunodeficiency; 10) Known to have active tuberculosis; 11) Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 12) Known brain metastases; 13) Patients with a higher risk of bleeding or perforation due to tumor invasion of adjacent organs (aorta or trachea) of esophageal and gastric lesions, or patients who have formed fistulas. The burden of liver metastases accounts for more than 30% of the entire liver volume; 14) Severe infections that are active or not well controlled; 15) Symptomatic congestive heart failure (Class II-IV of the New York Heart Association) or symptomatic or poorly controlled arrhythmia; uncontrolled arterial hypertension (systolic blood pressure >= 160mmHg or diastolic blood pressure) even with standard treatment >= 100mmHg); 16) Any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; 17) A history of deep venous thrombosis, pulmonary embolism, or any other severe thromboembolism within 3 months before enrollment (implantable venous infusion port or catheter-derived thrombosis, or superficial venous thrombosis is not considered ? Severe thromboembolism); 18) Uncontrolled metabolic disorders or other non-malignant tumor organs or secondary reactions to systemic disease or cancer, and may lead to higher medical risks and / or uncertainty in survival assessment; 19) Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh grade B or more severe cirrhosis; 20) Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA viral load >= 103 copies / mL or> 200IU / ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive); 21) History of other primary malignancies, except: Complete remission of malignant tumors for at least 2 years before enrollm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;PFS;OS;Safety; | — |
Countries
China
Contacts
Public ContactLiang Jun, XiognJianping
Peking University International Hospital; The First Affiliated Hospital of Nanchang University
Outcome results
None listed