- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07607210
A Clinical Study of SHR-1701 Combined With Chemotherapy for the Perioperative Treatment of Locally Advanced Resectable Siewert Type II Adenocarcinoma of the Esophagogastric Junction
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
Kontakter og lokationer
Studiekontakt
- Navn: Ziqiang Tian
- Telefonnummer: 18531118000
- E-mail: tizq12@vip.163.com
Studiesteder
-
-
Hebei
-
Shijiazhuang, Hebei, Kina
- The Fourth Hospital of Hebei Medical University
-
Kontakt:
- Ziqiang Tian
- Telefonnummer: +8618531118000
- E-mail: tizq12@vip.163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
1.Age:18-75 years old, male or female; 2.Pathologically confirmed Siewert Type II adenocarcinoma of the gastroesophageal junction; 3.Clinical stage cT3-4aN1-3M0; 4.Low to moderate HER2 expression or no expression (IHC 2+ and FISH- / IHC 1+ / IHC -); 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 6.At least one measurable lesion (according to RECIST 1.1 criteria); 7.Expected survival ≥ 3 months; 8.Normal functioning of major organs, i.e. meeting the following criteria:
routine blood tests:
- HB≥90g/L;
- ANC≥1.5×109/L;
- PLT≥100×109/L;
biochemical examination:
- ALT and AST<2.5ULN(liver metastasis: ALT and AST<5ULN);
- TBIL≤1.5ULN;
- Creatinine ≤1.5ULN; 9.Left ventricular ejection fraction is >50%; 10.Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks following the last administration of the study drug; 11. Participants were willing to join in this study, written informed consent, good adherence and co-operation with follow up.
Exclusion Criteria:
- Known signs of active bleeding from the lesion (except for a positive fecal occult blood test);
- Diagnosis of HER2-positive adenocarcinoma of the stomach or gastroesophageal junction;
- Cardia or pyloric obstruction;
- Currently participating in an interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose;
- Known hypersensitivity to any monoclonal antibody or component of a chemotherapy agent (such as tegafur or albumin-bound paclitaxel) (history of Grade 3 or higher hypersensitivity reaction);
- Previous exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, or CTLA-4 antibody therapy, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways;
- Receipt of an attenuated live vaccine within 4 weeks prior to the first dose of study treatment, or planned administration during the study period;
- Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 14 days prior to the start of study treatment (dose > 10 mg/day of prednisone or other corticosteroids of equivalent potency);
- History of active autoimmune disease requiring systemic treatment within 2 years prior to the first dose;
- Congenital or acquired immunodeficiency (e.g., HIV infection);
- The investigator determines that the subject has other factors that may affect the study results or lead to the premature termination of the study, such as alcohol abuse, substance abuse, other serious illnesses (including mental disorders) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors that may compromise the subject's safety;
- Pregnant or breastfeeding women;
- Evidence of medical history or disease that may interfere with trial results or prevent the subject from participating in the study throughout its duration, abnormal treatment or laboratory test results, or other circumstances deemed by the investigator to make the subject unsuitable for enrollment; or other potential risks identified by the investigator that render the subject unsuitable for participation in this study.
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: SHR-1701+SOX
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
|
SHR-1701: 1800mg, iv, d1, q3w; SOX: S-1:40 mg (BSA<1.25 m2) , 50 mg (BSA1.25-1.5 m2) , or 60 mg (BSA≥ 1.5 m2) , po bid d1-14; Oxaliplatin:130 mg/m2 IV D1;
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
pathological Complete Response(pCR)
Tidsramme: 1-year
|
No residual invasive cancer cells were found under microscopic examination of the resected tumor tissue and regional lymph node samples.
|
1-year
|
|
R0 resection rate
Tidsramme: 1-year
|
The tumor was completely removed during surgery, and microscopic examination of the resected tissue margins revealed no residual cancer cells.
|
1-year
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Major Pathological Response(MPR)
Tidsramme: 1-year
|
Following neoadjuvant therapy, the proportion of viable tumor cells observed under a microscope in the surgically resected specimen is ≤10%.
|
1-year
|
|
PFS(Progression-Free Survival)
Tidsramme: 3 years
|
The time from the start of treatment until tumor progression or death from any cause.
|
3 years
|
|
OS(Overall Survival )
Tidsramme: 3 years
|
Time from enrollment to death from any cause.
For subjects who were still alive at the time of the last follow-up, their overall survival was censored on the date of the last follow-up.
|
3 years
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Ziqiang Tian, Hebei Medical University Fourth Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Andre undersøgelses-id-numre
- AZL-EJC
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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Siewert Type II Adenocarcinoma of the Esophagogastric Junction
-
P. Herzen Moscow Oncology Research InstituteA.Loginov Moscow Clinical Scientific CenterRekrutteringSiewert Type II Adenocarcinoma af Esophagogastric Junction | Mavekræft (GC) | Siewert Type III Adenocarcinoma af Esophagogastric JunctionRusland
-
St. James's Hospital, IrelandUkendtBarrett Esophagus | Siewert Type II Adenocarcinoma af Esophagogastric Junction | Spiserørskræft | Siewert Type I Adenocarcinoma af Esophagogastric Junction | Siewert Type III Adenocarcinoma af Esophagogastric JunctionIrland
-
Cancer Institute and Hospital, Chinese Academy...RekrutteringSiewert Type II Adenocarcinoma af Esophagogastric JunctionKina
-
Melissa LumishSuspenderetSiewert Type II Adenocarcinoma af Esophagogastric Junction | Adenocarcinom spiserør | Siewert Type I Adenocarcinoma af Esophagogastric Junction | Lokalt avanceret adenocarcinomForenede Stater
-
West China HospitalRekrutteringTilbagevenden | Neoplasmer i maven | Siewert Type II Adenocarcinoma af Esophagogastric Junction | Siewert Type III Adenocarcinoma af Esophagogastric JunctionKina
-
P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health...AfsluttetSpiserørskræft | Spiserørskræft | Siewert Type I Adenocarcinoma af Esophagogastric Junction | Siewert Type III Adenocarcinoma af Esophagogastric JunctionDen Russiske Føderation, Hviderusland
-
Guangdong Provincial Hospital of Traditional Chinese...RekrutteringSiewert Type II Adenocarcinoma af Esophagogastric Junction | Esophagogastric Junction AdenocarcinomKina
-
University of BolognaAfsluttetSiewert Type II Adenocarcinoma af Esophagogastric JunctionItalien
-
Xijing Hospital of Digestive DiseasesFirst Affiliated Hospital Xi'an Jiaotong University; Henan Provincial People... og andre samarbejdspartnereRekrutteringSiewert Type II Adenocarcinoma af Esophagogastric JunctionKina
-
P. Herzen Moscow Oncology Research InstituteNational Medical Research Radiological Centre of the Ministry of Health...Ikke rekrutterer endnuMavekræft | Mavekræft | Siewert Type III Adenocarcinoma af Esophagogastric JunctionDen Russiske Føderation
Kliniske forsøg med SHR-1701+SOX
-
Jingdong ZhangRekrutteringGastroøsofageal Junction Adenocarcinom | Mavekræft (GC)Kina
-
Jiangsu HengRui Medicine Co., Ltd.Trukket tilbageIkke-småcellet lungekræft
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringLokalt avanceret eller metastatisk ikke-småcellet lungekræftKina
-
Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnuNasopharyngealt karcinomKina
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringMetastatisk mavekræft | Gastroøsofageal Junction Adenocarcinom | Avanceret mavekræftKina
-
Jiangsu HengRui Medicine Co., Ltd.Rekruttering
-
Shanghai Chest HospitalIkke rekrutterer endnu
-
Atridia Pty Ltd.AfsluttetAvanceret solid tumorAustralien
-
Jiangsu HengRui Medicine Co., Ltd.Aktiv, ikke rekrutterende
-
Hong QiuRekrutteringCRC (kolorektal cancer)Kina