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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects with advanced gastric cancer who have been included in first-line treatment and have received systemic chemotherapy in the past. Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 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 duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles. |
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| Group 2 | Experimental | Advanced gastric cancer subjects included in the first-line treatment progression, who have previously received systemic chemotherapy combined with immunotherapy in the first-line treatment Administration method: Camrelizumab 200mg, d1, q3w, Albumin bound paclitaxel 100mg/m2 on days 1 and 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 duration of administration for Camrelizumab is 2 years, while the longest duration of treatment for albumin bound paclitaxel is 6-8 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| mPFS | median Progression free survival | [Time Frame: The longest follow-up period from the patient's enrollment to disease progression or death from any cause is 2 years] |
| Measure | Description | Time Frame |
|---|---|---|
| mOS | median survival time | [Time Frame: The longest follow-up period from the patient's enrollment to death from any cause is 2 years] |
| DCR | Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
History of gastrointestinal perforation and/or fistula within 6 months prior to the first use of medication;
There is uncontrollable pleural effusion, pericardial effusion, or peritoneal effusion that requires repeated drainage;
History of allergies to monoclonal antibodies, any component of Carilizumab, or albumin bound paclitaxel;
Have received any of the following treatments:
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/exclusion criteria;
Patients with central nervous system metastases;
Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to the above diseases or syndromes); Excluding childhood asthma/allergies with vitiligo or those who have already recovered, patients who do not require any intervention in adulthood; Autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin;
Have a history of immune deficiency, including HIV test positive, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation, or active hepatitis (hepatitis B reference: HBV DNA test value exceeds 500 IU/ml or 2500 copies/mL);
The subject has uncontrolled cardiovascular clinical symptoms or diseases, including but not limited to: (1) NYHA class II or above heart failure; (2) Unstable angina pectoris; (3) Have experienced myocardial infarction within one year; (4) Clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or are still poorly controlled after clinical intervention;
Within 4 weeks prior to the first use of the investigational drug, there has been a severe infection (CTCAE 5.0>grade 2), such as severe pneumonia requiring hospitalization, bacteremia, infection complications, etc; Baseline chest imaging examination suggests the presence of active pulmonary inflammation, symptoms and signs of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, except for prophylactic use of antibiotics;
History of interstitial lung disease (excluding history of radiation pneumonia and non infectious pneumonia that have not been treated with steroids);
Patients with active pulmonary tuberculosis infection found through medical history or CT examination, or patients with a history of active pulmonary tuberculosis infection within the past year before enrollment, or patients with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment;
Diagnosed with any other malignant tumor within 5 years prior to the first use of the investigational drug, except for malignant tumors with low-risk metastasis and mortality risk (5-year survival rate>90%), such as basal cell or squamous cell carcinoma or cervical carcinoma in situ that have been adequately treated;
Pregnant or lactating women;
According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.
According to the researcher's assessment, there may be other factors that could force the subject to terminate the study midway, such as having other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the subject's safety or the collection of trial data.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zuoxing Niu, Prof. | Contact | +86 13506413687 | nzxsdth@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zuoxing Niu, Professor | Shandong First Medical University Affiliated Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University Affiliated Cancer Hospital | Recruiting | Jinan | Shandong | 250021 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D013660 | Taxes |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Nab paclitaxel | Drug | 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. |
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| [Time Frame: The longest follow-up period from enrollment to the first efficacy evaluation is 3 months] |
| safety:Record the incidence rate of all adverse events | Record the incidence rate of all adverse events | [Time Frame: From enrollment until 90 days after the last dose of medication] |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |