Gastric Cancer, Second-line Therapy
Conditions
Keywords
Immune checkpoint inhibitors；, Camrelizumab
Brief summary
This study was an open, single center, prospective cohort study design. Subjects with advanced gastric cancer who had received first-line chemotherapy (cohort 1) and systematic chemotherapy combined with immunotherapy (cohort 2) were included in this study. 20 cases were included in each population, and a total of 40 subjects were planned to be included.
Detailed description
1. main research purposes: Objective To observe the objective response rate (ORR) of carrelizumab combined with albumin paclitaxel in the second-line treatment of patients with advanced gastric cancer who previously received or did not receive immunotherapy. 2. secondary research purposes: Objective To observe the progression free survival (PFS), overall survival (OS), disease control rate (DCR) and safety of carrelizumab combined with albumin paclitaxel in the second-line treatment of patients with advanced gastric cancer who received or did not receive immunotherapy.
Interventions
DRUGCamrelizumab
Camrelizumab 200mg，d1，q3w.Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest duration of use for Carilizumab is 2 years
DRUGNab paclitaxel
nab-paclitaxel 100mg/m2 D1、8，q3w， Treatment until disease progression, toxicity intolerance, initiation of new anti-tumor therapy, withdrawal of information or researcher's judgment that the subject needs to withdraw from the study treatment. The longest treatment time for albumin bound paclitaxel is 6-8 cycles.
Sponsors
Shandong Tumor Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18 to 75 years old, both male and female are acceptable; 2. Patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma diagnosed by histology or cytology; 3. Gastric cancer patients who have previously received first-line systemic chemotherapy (queue 1) or systemic chemotherapy combined with immunotherapy (queue 2) for progression; For intervention group 2, the best response to first-line immunotherapy is CR or PR or SD ≥ 3 months; 4. According to the evaluation criteria for solid tumor efficacy 1.1 (RECIST v1.1), there should be at least one measurable lesion that has not received local treatment such as radiotherapy (lesions located within the previously irradiated area can also be selected as target lesions if progression is confirmed); 5. ECOG score: 0-1 point; 6. Expected survival period ≥ 12 weeks; 7. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula); 8. Female subjects with fertility, as well as male subjects with partners who are fertility women, are required to use a medically approved contraceptive measure (such as intrauterine devices, birth control pills, or condoms) during the study treatment period, at least 6 months after the last use of Carilizumab, and at least 6 months after the last use of chemotherapy; 9. HER2 negative; 10. Voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
1. History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication; 2. There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage; 3. History of allergies to monoclonal antibodies, any component of Carilizumab, or albumin bound paclitaxel; 4. Have received any of the following treatments: 1. Patients who have experienced serious adverse reactions to immunotherapy in the past and are deemed unsuitable for continued use of immunotherapy by the researchers; 2. Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug; 3. Simultaneously enrolled in another clinical study, unless it is an observational (non interventional) clinical study or an interventional clinical study follow-up; 4. Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug; 5. Subjects who need to receive corticosteroids (equivalent to\>10mg prednisone per day) within 2 weeks prior to the first use of the study drug. Other special circumstances require communication with the researcher. In the absence of active autoimmune diseases, inhalation or local use of steroids and corticosteroids with a dosage greater than 10mg/day of prednisone efficacy dose are allowed as substitutes for adrenal cortex hormones; 6. Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug; 7. Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug; 8. Patients who have received previous treatment with paclitaxel drugs; 5. The toxicity of previous anti-tumor treatments has not recovered to ≤ CTCAE 5.0 Grade 1 (excluding hair loss) or the level specified in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mPFS | [Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years] | median Progression free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mOS | [Time Frame: The longest follow-up period from the patient's enrollment to death from any cause is 2 years] | median survival time |
| DCR | [Time Frame: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months] | Disease Control Rate |
| safety：Record the incidence rate of all adverse events | [Time Frame: From enrollment until 90 days after the last dose of medication] | Record the incidence rate of all adverse events |
Countries
China
Contacts
CONTACTZuoxing Niu, Prof.
PRINCIPAL_INVESTIGATORZuoxing Niu, Professor
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed