Status and phase
Conditions
Treatments
About
This study is an open, exploratory clinical study. Eligible patients with advanced second-line gastric/gastroesophageal junction adenocarcinoma signed an informed consent form, were screened for enrollment, and were entered into Group A (non-immune retreatment group-patients who had failed previous first-line treatment with standard chemotherapy) and Group B (immune retreatment-patients who had obtained SD and above with best efficacy of previous first-line treatment with PD-1 antibody) based on whether they had received previous first-line treatment with PD-1 antibody. All patients received a combination of envafolimab and lenvatinib in combination with paclitaxel-albumin and were treated until disease progression, withdrawal of informed consent by the subject, loss to follow-up, and death, where treatment did not exceed 2 years. Clinical oncologic imaging assessments were performed using iRECIST every 8 weeks during treatment; safety assessments were performed using CTCAE 5.0, and adverse events were recorded throughout the study up to 30 days after the end of treatment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed written informed consent prior to enrollment.
Age 18-80 years.
Negative for HER2
Diagnosis confirmed by histological examination and/or cytological examination combined with imaging assessment of advanced metastatic gastric/gastroesophageal junction adenocarcinoma.
Failure of previous first-line therapy. Group A (non-immune retreatment): patients who have failed prior chemotherapy with first-line standard therapy. Group B (immune retreatment): patients who received previous first-line PD-1 antibody therapy with optimal efficacy SD and on.
ECOG score: 0 to 1.
At least one measurable lesion (≥10 mm long diameter on CT scan for non-lymph node lesions and ≥15 mm short diameter on CT scan for lymph node lesions according to iRECIST criteria).
Adequate organ function with.
A predicted survival of ≥ 3 months.
Female patients must be non-pregnant and non-lactating and are required to use a medically approved form of contraception (e.g., IUD, pill or condom) during study treatment and for at least 120 days after study completion, and are not allowed to donate eggs to another person or freeze them for fertilization and propagation during this period.
Exclusion criteria
Symptomatic brain metastases.
Known MSI-H/dMMR.
A prior history of a primary tumor outside of the gastric/gastroesophageal junction
Active autoimmune disease or autoimmune disease with potential for recurrence such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enterocolitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, previous thyroid surgery cannot be included; subjects with vitiligo or complete remission of asthma in childhood and adult who do not require any intervention afterwards can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
Subjects with any severe and/or uncontrolled disease. including.
Research treatment related to.
Those with a history of severe allergy.
Women who are pregnant or breastfeeding
At risk for bleeding, or with coagulation disorders, or undergoing thrombolytic therapy
Those with a history of psychotropic substance abuse and unable to abstain or with psychiatric disorders
Subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment In the judgment of the investigator, subjects who, in the judgment of the investigator, have a concomitant disease that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or subjects for whom other reasons are deemed to exist that make them unsuitable for enrollment
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal