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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Beijing
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Beijing, Beijing, China, 100050
- Beijing Friendship Hospital
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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
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Combination therapy of 4 drugs, 21 days for one cycle.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
R0 resection rate
Tijdsspanne: 3 years
|
proportion of patients for whom radical resection can be achieved
|
3 years
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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ORR
Tijdsspanne: 3 jaar
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objectief responspercentage
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3 jaar
|
|
DFS
Tijdsspanne: 3 years
|
disease free survival (period)
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3 years
|
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3-year DFS
Tijdsspanne: 3 years
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3-year disease free survival (rate)
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3 years
|
|
PFS
Tijdsspanne: 3 years
|
progression free survival (period)
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3 years
|
|
OS
Tijdsspanne: 3 years
|
overall survival (period)
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3 years
|
|
1-year OS
Tijdsspanne: 1 year
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1-year overall survival (rate)
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1 year
|
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3-year OS
Tijdsspanne: 3 years
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3-year overall survival (rate)
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3 years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Wei Deng, Beijing Friendship Hospital
Studie record data
Bestudeer belangrijke data
Studie start (Verwacht)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata
- Neoplasmata per site
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Maagneoplasmata
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, fytogeen
- Proteïnekinaseremmers
- Paclitaxel
- Apatinib
Andere studie-ID-nummers
- BFH-CamrelizumabCombo4
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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