- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04777162
Tislelizumab Plus Anlotinib for Immunotherapy Resistant Gastrointestinal Cancer
Efficacy and Safety of Tislelizumab Plus Anlotinib in PD-1/PD-L1 Resistant Metastatic Gastric or Colorectal Cancer: a Single Arm Phase II Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100142
- Rekruttering
- Beijing Cancer hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- ECOG scored 0 or 1, ≥18 years old, expected OS≥3 months;
- Histology confirmed unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma or colorectal cancer;
- ≥1 evaluable lesion based on RECIST 1.1;
Patients received PD-1/PD-L1 in the last treatment line, and should meet following conditions:
i) there was no severe immune-related adverse events, ii) the duration between tumor progression and screening should be 3-12 weeks, iii) the best evaluation results should be PR or CR when receiving PD-1/PD-L1 treatment but progression was confirmed in the latest evaluation, iv) patients were diagnosed with special pathology subtypes, that are sensitive to immunotherapy, such as dMMR, MSI-H tumors, or gastric cancer with PD-L1 CPS≥10, PFS≥6 months in the last treatment line;
- laboratory test should meet following standard: i) HB≥90g/l, neutrophils≥1.5*10^9/L, plt≥100*10^9, ii) ALT and AST<2.5xULN (5ULN for liver metastatic patients), TBIL≤2×ULN, Cr≤1.5×ULN, and Ccr>50μmol/L iii) APTT, INR and PT≤1.5×ULN iv) LVEF≥50%
- for female participants, Hcg should be negative and both male and female participants should have contraception measures
- participants should be informed consent, and voluntary.
Exclusion Criteria:
- received anlotinib or other TKIs previously;
- allergic to other monoclonal antibody before the treatment;
- diagnosed with other malignancy in last five years (cured skin basal carcinoma, prostate cancer or cervical caner in situ were excluded)
- concurrent with other active autoimmune disease;
- any condition that require immune suppressor, such as cortisol (>10mg/d prednisone equally), CTX;
- conditions affect oral absorption (eg: dysphagia, intestinal obstruction; chronic diarrhea);
- uncontrolled pleural effusion, hydropericardium and seroperitoneum;
- brain metastasis;
- received other anti-tumor treatment in past 3 weeks, eg: surgery, radiotherapy, target therapy, immunotherapy, and traditional Chinese therapy (target therapy less than 5 half-life period, 5-Fu less than 14 days were excluded);
- concurrent with uncontrolled other diseases, i) hypertension (>150/90mmHg) ii) unstable angina pectoris, ≥ level 2 heart failure, arrhythmia within last 6 months; iii) clinical meaningful liver disease, eg: active HBV/HCV hepatitis; iv) HIV positive; v) uncontrolled diabetes; vi) urine protein ≥++ or 24h urine protein >1g;
- injected vaccine in past 4 weeks, or administrated with antibiotics;
- investigator assumed improper conditions, such as mental disease, family or society factors.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: tislelizumab+anlotinib
patients will be administrate with dual drugs, tislelizumab plus anlotinib.
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For included participants, tislelizumab would be administrated 200mg q3w iv.
Patients will be administrated with Anlotinib 12mg p.o. d1-d14 q3w.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
objective response rate
Tidsramme: 2 years
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the rate of patients reached PR or CR based on RECIST 1.1
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2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
progression-free survival
Tidsramme: Up to 2 years
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the time from recruiting to death or progression
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Up to 2 years
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overall survival
Tidsramme: Up to 2 years
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the time from recruiting to death
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Up to 2 years
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Tislelizumab plus Anlotinib
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Mavekræft
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Medtronic - MITGAfsluttet
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetSleeve Gastrectomy | Roux en Y Gastric BypassForenede Stater
Kliniske forsøg med Tislelizumab
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Peking University Cancer Hospital & InstituteRekrutteringIkke-småcellet lungekræft | Konsoliderende immunterapi | Strålebehandling eller sekventiel kemoradiationKina
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Jiangsu Yahong Meditech Co., Ltd aka AsierisRekruttering
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Fudan UniversityAktiv, ikke rekrutterendeHepatocellulært karcinomKina
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Henan Cancer HospitalIkke rekrutterer endnu
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Shanghai Gopherwood Biotech Co., Ltd.Rekruttering
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GeneScience Pharmaceuticals Co., Ltd.RekrutteringOndartede faste tumorerKina
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Fudan UniversityRekrutteringIldfast malign ascitesKina
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Peter MacCallum Cancer Centre, AustraliaRekruttering
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Fudan UniversityIkke rekrutterer endnu
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Huihua XiongIkke rekrutterer endnuMetastatisk triple-negativ brystkræftKina