- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04258644
Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer
Efficacy and Safety of Camrelizumab in Combination With Apatinib Mesylate, Paclitaxel-albumin and S-1 for Translational Treatment of Gastric Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Zhongtao Zhang
- Telefonnummer: 8618811792819 8618811792819
- E-post: zhongtao.z@139.com
Studieorter
-
-
Beijing
-
Beijing, Beijing, Kina, 100050
- Beijing Friendship Hospital
-
Kontakt:
- Zhongtao Zhang, M.D.
- Telefonnummer: 8618811792819 8618811792819
- E-post: zhongtao.z@139.com
-
Huvudutredare:
- Kai Pang
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- age:18~70; expected survival>3 months
- pathologically diagnosed gastric cancer or esophageal-gastric-junction cancer, being predominantly adenocarcinoma
- no previous treatment of anti-cancer drugs
- ECOG score 0~2
- CT/MRI/PET-CT diagnosed as unresectable
- no disfunction of major organs
lab results satisfy the following criteria:
- Hb≥90g/L
- WBC≥3.5×109/L
- Neutrophil≥1.5×109/L
- Plt≥100×109/L
- ALT、AST≤2.5 upper limit (≤5 upper limit for patients with liver metastasis)
- Tbil≤1.5 upper limit
- serum creatinine≤1.5 upper limit
7.women at child-bearing age must be tested negative within 7 days before inclusion, and must be willing to take contraception measures during treatment and within 12 weeks after last dose of treatment; men must be sterilized or willing to take contraception measures during treatment and within 12 weeks after last dose of treatment 8.willing to join this research with hand-signed written Informed consent 9.good compliance for follow-up
Exclusion Criteria:
- patients with positive HER-2 test
- with conditions that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
- allergic to carrizumab for injection, apatinib mesylate, paclitaxel for injection (albumin binding type) and tS-1 or relevant drug excipients; allergic to any other monoclonal antibodies; cannot tolerate radiation toxicity;
- with active autoimmune disease or autoimmune disease history, such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy); patients with complete remission of childhood asthma and require no intervention can be included, whereas those who need medical intervention with bronchodilator cannot be included
- with congenital or acquired immune defects, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the lower detection limit of the analysis method) or combined hepatitis B and hepatitis C co infection
- immunosuppressive drugs were used within 14 days before the first use of the study drug, excluding nasal spray and inhaled corticosteroids or systemic steroids in physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids for equivalent amount);
- inoculated live attenuated vaccine within 4 weeks before the first administration or during the study period
- severe infection (requiring intravenous drip of antibiotics, antifungal or antiviral drugs) within 4 weeks before the first administration, or fever> 38.5° C of unknown cause during screening / before the first administration
- known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- objective evidence indicating previous or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced pneumonia, drug-related pneumonia, severe impairment of lung function, etc
- patients with hypertension that cannot be restored to the normal range (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg) after treatment with antihypertensive drugs for 3 months
- patients with uncontrolled clinical symptoms or diseases of the heart, including but not limited to congestive heart failure (NYHA grade > II); unstable or severe angina; acute myocardial infarction within 6 months; patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention; left ventricular ejection fraction (LVEF) < 50%
- patients at risk of serious bleeding, including but not limited to severe bleeding (bleeding > 30 ml within 3 months), hemoptysis (bleeding > 5 ml within 4 weeks), and thromboembolism events (within the past 12 months)
- with symptoms indicating Grade 2+ peripheral neuropathy
- participating in other clinical trials, or participating in any clinical study for drugs within previous 4 weeks
- other situations that the researchers regard as not suitable for inclusion.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Camrelizumab+Apatinib+Paclitaxel-albumin+S-1
Camrelizumab:D1, 200 mg ivgtt Apatinib Mesylate:D1~21, 250 mg, po qd Paclitaxel-albumin:D1&D8, 100~120 mg/m2 S-1:D1~14, 60mg bid
|
Combination therapy of 4 drugs, 21 days for one cycle.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
R0 resection rate
Tidsram: 3 years
|
proportion of patients for whom radical resection can be achieved
|
3 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
ORR
Tidsram: 3 år
|
objektiv svarsfrekvens
|
3 år
|
DFS
Tidsram: 3 years
|
disease free survival (period)
|
3 years
|
3-year DFS
Tidsram: 3 years
|
3-year disease free survival (rate)
|
3 years
|
PFS
Tidsram: 3 years
|
progression free survival (period)
|
3 years
|
OS
Tidsram: 3 years
|
overall survival (period)
|
3 years
|
1-year OS
Tidsram: 1 year
|
1-year overall survival (rate)
|
1 year
|
3-year OS
Tidsram: 3 years
|
3-year overall survival (rate)
|
3 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Wei Deng, Beijing Friendship Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Förväntat)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i magen
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Proteinkinashämmare
- Paklitaxel
- Apatinib
Andra studie-ID-nummer
- BFH-CamrelizumabCombo4
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
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